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

Model Number	82-3832
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12216556
• Report Number: 3013886523-2021-00326
• Device Sequence Number: 14329932
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(17)231031(10)3276913
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1