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

Catalog Number	823100
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2024
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 facility reported a hakim valve (id 823100) was implanted on (b)(6) 2004.The valve had "no visible point", setting could not be verified, valve could not be set; therefore, it was explanted and replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation: dhr - no discrepancies were noted when released to stock.Failure analysis - the valve was visually inspected; no defect was noted.The valve passed the tests for occlusion, leaks, and reflux.The valve failed the test for programming; the cam mechanism wiggled.The pressure test could not be performed as the device could not be programmed.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the cam, base plate and on the seat of the ruby ball.Root cause - the root cause for the issue reported by the customer is due to biological debris found during the investigation.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• 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: 20369221
• Report Number: 3013886523-2024-00304
• Device Sequence Number: 17857590
• Product Code: JXG
• UDI-Device Identifier: 10381780534457
• UDI-Public: 10381780534457
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2024
• 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): 12/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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