MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION HERMETIC LUMBAR CATHETER TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS5010

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/08/2018

Event Type  malfunction  

Event Description

Attempt was made to remove the guidewire, which appeared to be stuck to the catheter.After gentle traction was applied only the guidewire was removed in its entirety but after further inspection it did appear to have tear midway.After careful inspection of the catheter the proximal 30 cm of catheter appeared to have multiple tears in it.Manufacturer response for lumbar catheter, hermetic lumbar catheter (per site reporter): integra qa researching issue.

• Brand Name: HERMETIC LUMBAR CATHETER TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 11 cabot blvd.; mansfield MA 02048
• MDR Report Key: 8174524
• MDR Text Key: 130686572
• Report Number: 8174524
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: (01)10381780071082
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS5010
• Device Catalogue Number: INS5010
• Device Lot Number: 2892476 OR 1173613
• 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: 12/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1