MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE CLYNDRICAL W PRECHA; CHPV

Catalog Number 823110

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2021

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 the hakim programmable valve could not be adjusted and it was explanted.The valve was implanted in 2014.The patient is a (b)(6) y/o male patient.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Corrected data d1, d2, d4.The hakim valve was returned for evaluation: dhr - lot cpdch0, conformed to the specifications when released to stock failure analysis - the valve was visually inspected; the silicone housing was cut/torn over the distal connector, and marks were noted in the distal connector.The valve failed the tests for programming, leak and pressure.The valve passed the test for occlusion, reflux.The valve was dismantled and was examined under microscope at appropriate magnification: a small white debris was found stuck between the ruby ball and the seat of the ruby ball, this debris was putting pressure on the spring stopping the cam mechanism from moving correctly and stopping the ruby ball from being seated correctly.Root cause: - the root cause for the programing issue reported by the customer, is due to a debris interfering with the valve mechanism.- the root cause for the pressure issue noted during the investigation is due to a debris interfering with the valve mechanism.- the root cause for the cut/tear in the silicone housing and the marks in the connector noted during the investigation, is probably due to wrong handling, as noted in the ifu: silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.

Event Description

N/a.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12216437
• MDR Text Key: 263091671
• Report Number: 3013886523-2021-00315
• 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: 09/29/2021

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: 03/31/2018
• Device Catalogue Number: 823110
• Device Lot Number: CPDBHO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR