MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 823100

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 12/16/2020

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 that the hakim programmable valve was implanted in a male patient on (b)(6) 2020.The valve was explanted on (b)(6) 2020 and replaced with a new one as there was leakage noted while performing permeability at the chamber joint.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The hakim valve was returned for evaluation; device history record (dhr) - lot 4434194 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected, a cut/tear was noted in the silicone housing at the distal end, just before the connector.The position of the cam when valve was received was 90mmh2o.The valve was hydrated.The valve was flushed no occlusion was noted at the ruby ball but leaked from the cut/tear in the silicone housing at the distal end, just before the connector.The valve was leak tested and leaked from the cut/tear in the silicone housing at the distal end, just before the connector.The valve could not be reflux tested, due to the leaked from the cut/tear in the silicone housing at the distal end, just before the connector.The valve passed the test for programming and pressure.The root cause for the issue reported by the customer is due to the cut/tear in the silicone housing at the distal end, just before the connector.The root cause for the cut/tear in the silicone housing at the distal end just before the connector could be due to handling or a sharp or pointed object coming into contact with the silicone, as noted in the ifu silicone has a low cut/tear resistance.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11166861
• MDR Text Key: 230252967
• Report Number: 3013886523-2021-00019
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823100
• Device Lot Number: 4434194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1