MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM VENTRICULAR CATH; STANDARD CATHETERS

Catalog Number 823041

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2021

Event Type  Injury  

Event Description

2 of 2 reports.Other mfg report number: 3013886523-2021-00577.A physician reported a certas valve (828804) and a ventricular catheter (823041) were implanted in a (b)(6) male patient via v-p shunt on (b)(6) 2021 with unknown setting.The patient was stable, but ct images confirmed that the ventricular catheter was disconnected.The valve and the catheter were removed on (b)(6) 2021.The patient is in the follow up.

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The ventricular catheter (id 823041) was returned for evaluation.Failure analysis - the proximal connector of the valve and the catheter were visually inspected, marks in the proximal connector were noted, no other defects were noted, no defects were noted with the ends of the catheter, no suture tie marks were noted around the catheter.Disconnection was probably due to catheter not being tied to valve.The root cause for the issue reported by the customer is probably due to the catheter not being sutured to the connector.The root cause for the marks in the proximal connector noted during the investigation are due to a sharp / pointed object or unshod forceps coming into contact with the connector.

Event Description

N/a.

• Brand Name: HAKIM VENTRICULAR CATH
• Type of Device: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13171417
• MDR Text Key: 288591373
• Report Number: 3013886523-2021-00578
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K944222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 823041
• Device Lot Number: 3650297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male