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

Catalog Number	823110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A physician reported a hakim valve (id 823100) was implanted due to unknown reason via ventriculoperitoneal (v-p) shunt, approximately 20 years ago, with unknown setting.Due to dysfunction, the valve was removed and replaced.The details of the failure are unknown.According to information provided, it is unknown if the patient experienced any signs and symptoms due to product failure.It is also unknown when was the explant/replacement date.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id (b)(6)) was returned for evaluation.Device history record (dhr) - the product code 82-3110 with lot p1239, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 30 mmh2o.The valve was visually inspected, a needle hole in the housing.The valve was hydrated.The valve passed the test for programming, occlusion, reflux and pressure.The valve was leak tested and passed, only leak from needle hole.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20212692
• Report Number: 3013886523-2024-00282
• Device Sequence Number: 15327079
• Product Code: JXG
• UDI-Device Identifier: 10381780534471
• UDI-Public: 10381780534471
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 Catalogue Number: 823110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/1997
• 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 Age: 72 YR
• Patient Sex: Male