MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number	823162
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve was implanted in a (b)(6) male patient via v-p shunt on (b)(6) 2021 with 80 mmh2o.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).The patient was still ill after the valve was placed and the patient's condition did not change even when the setting was lowered to 60mmh2o.The valve was removed and replaced on (b)(6) 2022.
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
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the valve, product code 82-3162 with lot 4959988, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a cut/tear in the needle chamber was noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve was leak and leaked from the cut/tear in the needle chamber.The valve was then pressure tested and failed the test.The valve passed the test for programming, occlusion, reflux and siphon guard.Root cause - the root cause for the issue reported by the customer, could be due the cut/tear in the silicone housing in the needle chamber.The root cause for the pressure issue noted during the investigation 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.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 13871733
• Report Number: 3013886523-2022-00111
• Device Sequence Number: 4692644
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)250831(10)4959988
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/29/2022

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: 08/31/2025
• Device Model Number: 823162
• Device Catalogue Number: 823162
• Device Lot Number: 49599988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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 Age: 5 YR
• Patient Sex: Male