Racz Catheter Adhesiolysis: Case Series of Device Malfunction and MAUDE Database Review

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Racz Catheter Adhesiolysis: Case Series of Device Malfunction and MAUDE Database Review

Jason E. Pope, M.D., Sukdeb Datta, M.D.
Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee

Introduction: Epidural adhesiolysis is performed with a Racz catheter. As the catheter is wire embedded and flexible, there are several reported complications, including knotted, sheared, or retained catheter segments. Additionally, the Spinal Cord Access (SCA) introducer may also lend itself to potential complications, including tissue anchoring and shear damage. Although no catheter complications have had any reported significant clinical consequence, the potential for patient morbidity exists, owing to the controversial decision making paradigm regarding surgical removal versus conservative treatment of retained fragments. We report two such complications and a review of MAUDE (Manufacturer and User Facility Device Experience Database) database to identify potential complications.

Case Series: After an uneventful epidural adhesiolysis on a patient with LBP, on removal the SCA introducer was found to be stretched with shear damage. The catheter was removed and the patient suffered no clinically significant sequela from the event (figure 1) . In the second instance, adhesiolysis was performed successfully and the catheter was removed so the wire could be reinserted and further adhesiolysis could be carried out. When this was done, the catheter unraveled from the wire (figure 2). The procedure was continued using another catheter. Considering these two complications, we conducted an online search of the MAUDE database to further identify similar complications

Methods: A review of the MAUDE database to determine the kind of reported complications associated with the Racz catheters and introducers from a variety of manufactures was performed by selecting all dates under simple search option with search criteria for “Racz catheters” and “SCA introducers.”

Results: A total of 45 reported complications were identified, of which 39 were RACZ catheter complications and 6 were SCA introducer malfunctions. Results will be presented.

Discussion: Although the catheter was introduced in 1981, problems with catheter integrity led to improvements in strength. Most of the complications occurred with removal. The incidence of neuraxial catheter breakage and retained segment is unknown, although the estimates are growing. The treatment strategy for retained catheter segments is largely controversial. Currently, the popular opinion centers on conservative management and to leave the retained indwelling nonferromagnetic catheters in place unless they are embedded in the subcutaneous tissue, the patient starts to develop symptoms, or the catheter was inserted caudally. Intrathecal and epidural indwelling broken catheters are managed similarly without any clinically significant adverse events, although surgical removal of the Racz catheter is strongly recommended. Proponents of removal site infectious complications associated with all foreign bodies, and metal may interfere with future radiologic investigations, ie magnetic resonance imaging.[figure1]

Anesthesiology 2008; 109 A1567

Figure 1