MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number	XXX-HAKIM PROGRAMMABLE VALVE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
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
2 of 2 reports.Other mfg report number: 3013886523-2024-00078.A facility reported a patient presented with hydrocephalus symptoms.A x-ray was taken on (b)(6) 2024 showing a broken catheter.The catheter and the hakim valve were explanted due to broken catheter.The valve was implanted in 2018 and the catheter in 2010.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (unitized), was returned for evaluation without the catheter.Dhr - lot 153061, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the needle guard part of the valve has been cut away and not returned, tie marks were noted in the proximal end of the valve, a cut in the silicone housing along the valve casing was also noted.The biological debris were noted inside the housing.The valve passed the tests for programming, occlusion, reflux and pressure.The valve was leak tested; only leak from cut.Root cause - no root cause could be determined as the catheter was not returned for investigation.A possible root cause for the issue reported by the customer, could be due to an issue at implantation phase (catheter too short / catheter damaged for example).The root cause for the cut/tear in the silicone housing along the valve casing" is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu, silicone has a low cut/tear resistance.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• 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: 18945390
• Report Number: 3013886523-2024-00079
• Device Sequence Number: 12525360
• Product Code: JXG
• UDI-Device Identifier: 10886704041467
• UDI-Public: (01)10886704041467(17)220831(10)153061
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2017
• 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
• Patient Sex: Unknown