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

Catalog Number	823111
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that after performing a regular checkup, requiring mri (3t), they noticed that the hakim valve (chpv id 823111) is ¿¿locked¿¿ in 30mm setting and medical staff could not re adjust it.The patient was presenting moderate symptoms of over-drainage (patient condition).Although the patient was in good condition, but with some medical issues, and in order to exclude that the cause was the malfunction of the valve, they decided to explant the chpv and implant a new certas valve on (b)(6) 2024.Patient is in good condition.The hakim valve was implanted in (b)(6) 2015.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation: dhr - lot ctfcg0, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; cut and marks were noted in the needle chamber.The valve failed the test for programming (the cam mechanism wiggled).The pressure test could not be performed because the device could not be programmed.The valve passed the tests for occlusion, leaks (no other leak than the cuts marks in the needle chamber were noted), and reflux.The valve was disassembled: was visually inspected under microscope at appropriate magnification: biological debris were found on the ruby ball, on the seat of the ruby ball and motor.A visual check of the magnetization motors was carried out, the valve passed the test.Root cause - the root cause for the issue reported by the customer is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.The root cause for the ¿cut marks¿ is due to a sharp or pointed object coming into contact with the valve or atypical handling, as noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: STD CHPV W PRECHAMBER UNITIZED
• Common Device Name: CHPV
• 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 08540 ; 6099362319
• MDR Report Key: 20578468
• Report Number: 3013886523-2024-00332
• Device Sequence Number: 18305303
• Product Code: JXG
• UDI-Device Identifier: 10886704041467
• UDI-Public: (01)10886704041467(17)200430(10)CTFCG0
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 823111
• Device Lot Number: CTFCG0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown