MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD STD CHPV W PRECHAMBER UNITIZED

Catalog Number 823111

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported overdrainage of a hakim valve.In (b)(6) 2021 the patient presented with ventrucular hemorrhage.The valve was explanted and replaced on (b)(6) 2021.Initial implantation was in 2003.

Event Description

N/a.

Manufacturer Narrative

The hakim valve was returned for evaluation: dhr - lot 1026055, serial number (b)(6) , conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a crack and a bump mark were noted in the valve casing, as well as a cut/tear in the silicone housing proximal end.The valve passed the tests for programming, occlusion and reflux.The valve could not be flushed, leak and pressure tested due to the cut/tear in the silicone housing proximal end.The root cause for the issue reported by the customer, is due to the cut/tear in the silicone housing at the proximal end of the valve.The root cause for the cut/tear in the silicone housing is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu, silicone has a low cut/tear resistance.The root cause for the crack and bump mark in the valve casing is due to the valve receiving a knock.

• Brand Name: STD CHPV W PRECHAMBER UNITIZED
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12178709
• MDR Text Key: 261905956
• Report Number: 3013886523-2021-00311
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K122118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1