MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S. LUMBAR CATHETER ACCESSORY KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 910121

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 03/24/2019

Event Type  malfunction  

Event Description

Md was unable to pull the guide wire back out - it was as if the guide wire was stuck inside the drain.This resulted in her having to completely remove the successfully placed drain and re-insert a new drain.She successfully placed the second drain but, again, the guide wire would not come out.This time, when she pulled the wire, it actually somehow managed to cut the drain tubing itself and both the remaining drain tubing and guide wire came out.This left only a very small portion (approximately 1 inch) of tubing exiting the patient's back.

• Brand Name: LUMBAR CATHETER ACCESSORY KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S.; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8495109
• MDR Text Key: 141327530
• Report Number: 8495109
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Device Lot Number: 0198547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2019
• Date Report to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA