MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC. BREVI-XL/2; RACZ CATHETER

Model Number 155-2342

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2014

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: on (b)(4) 2014, epimed examined that brevi-xl/2 catheter in question.During visual inspection, approximately 4.75" of the catheter's outer teflon coating was missing from the catheter's distal end.Furthermore, starting 4" from the catheter's distal tip, the catheter's first layer of coating (pet) was skived approximately 1 cm in length which exposed the catheter's wound spring.This indicates that the catheter had become severely caught/pinched within the patient's bone structure or other object.Per the physician's reports of the event, it appears that the patient's anatomy which contained "a lot of scar tissue" may have masked the seriousness of the resistance that was being felt by the physician.Nonetheless, when resistance was encountered, the physician should have referred to epimed's instructions for use to prevent any unnecessary damage to the catheter.

Event Description

On (b)(6) 2014, epimed's quality assurance department was notified of an event that had recently occurred involving epimed's brevi-xl/2, (catalog # 155-2342).The customer reported "during radiofrequency performance through via caudal route of nerve roots l5-s1, a cross-section of the plastic sheath surrounding the catheter occurs, leaving about 5 cm housed in the patient epidural space".The reported status of the patient was good.Epimed recommended that a neurosurgeon be consulted to retrieve the section of catheter from the patient; however, no information was provided from the physician/hospital whether a neurosurgeon had been consulted.The physician stated that the patient had arthritis with "a lot" of scar tissue, so he felt resistance in all moments, advancement, removing etc; and he thought that was the problem.

• Brand Name: BREVI-XL/2
• Type of Device: RACZ CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC.; 141 sal landrio dr.; johnstown NY 12095
• Manufacturer Contact: 141 sal landrio dr.; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 3807284
• MDR Text Key: 19323213
• Report Number: 1316297-2014-00002
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: 954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 155-2342
• Device Catalogue Number: 155-2342
• Device Lot Number: 11425416
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1