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

Catalog Number 910121

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2021

Event Type  No Answer Provided  

Event Description

Surgeon placed catheter with guidewire - went to remove.Guidewire was stuck in catheter when it pulled out of the catheter.Eventually, guidewire was sheared / thinned off toward the ends.All retrieved and catheter removed.New one inserted.

• Brand Name: LUMBAR CATHETER ACCESSORY KIT
• Type of Device: INTEGRA SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 11265482
• MDR Text Key: 230088404
• Report Number: MW5099129
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Catalogue Number: 910121
• Device Lot Number: 0220929
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 122