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

Model Number	NS5479
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/21/2022
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 was implanted on (b)(6) 2014 and explanted on (b)(6) 2022 due to leak.Upon removal, the valve tore away from the unitized rickham reservoir and there was a hole in the cylindrical chamber.
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 was implanted on (b)(6) 2014 and explanted on (b)(6) 2022 due to leak.Upon removal, the valve tore away from the unitized rickham reservoir and there was a hole in the cylindrical chamber.
Additional Manufacturer Narrative
The precision valve (id ns5479) was returned for evaluation.Failure analysis - the valve is a precision valve with 4 dots.The valve was visually inspected; the proximal connector was detached from the valve, a cut/tear in the silicone housing were the proximal connect should be connected was noted.The complaint is confirmed.The proximal connector was visually inspected a lot of marks were noted in the connector.The root cause for the leaking issue reported by the customer is due to the cut/tear in the silicone housing.The root cause for the cut/tear in the silicone housing 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.The root cause for the marks in the proximal connector are possible due to unshod forceps or sharp or pointed object coming into contact with the connector.

• 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 ; 6099362319
• MDR Report Key: 13536814
• Report Number: 3013886523-2022-00048
• Device Sequence Number: 4073022
• Product Code: JXG
• UDI-Device Identifier: 10886704048213
• UDI-Public: 10886704048213
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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 Model Number: NS5479
• Device Catalogue Number: NS5479
• Device Lot Number: 473756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 06/22/2022
• 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
• Patient Sex: Unknown