MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number 82-3832

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

The hakim valve was returned for evaluation.Device history record (dhr) - lot 3276913 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected, the silicone housing was cut/torn around the siphon guard, complaint is confirmed.The siphon guard was visually inspected marks were found in the siphon guard.The root cause for the problem reported by the customer, ¿the hakim valve was found broken through "ct "check.¿ 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

A facility reported hakim programmable valve was implanted in a patient on (b)(6) 2019, the patient recovered well after the procedure.Several months after the procedure, the patient felt not well, and the hakim valve was found broken through ct imaging.The patient was taken to surgery on (b)(6) 2021 for a shunt revision procedure and implanted with another of the same valve, 823832.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• 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: 12216556
• MDR Text Key: 263094274
• Report Number: 3013886523-2021-00326
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(17)231031(10)3276913
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 82-3832
• Device Catalogue Number: 823832
• Device Lot Number: 3276913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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