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

Model Number	823110
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
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 that after connecting the peritoneal and ventral catheters of a hakim valve (id (b)(4)), there is a low flow of water in the chamber part.When testing the actual valve the failure was not showing; however, a micro-check is required.The procedure was completed with a replacement product available.No patient contact or injury was reported; however, the event led to 3 hours surgical delay.The valve was used to treat hydrocephalus.
Additional Manufacturer Narrative
The hakim valver (id 823110) was returned for evaluation.Device history record (dhr) - the product code 82-3110 with lot 6498231, conformed to the specifications when released to stock.Failure analysis - -the position of the cam when valve was received was 150mmh2o.The valve was visually inspected; a cut/tear was noted in the ventricular catheter near the valve, also a cut/tear in the silicone housing of the valve near the distal connector on the side of the valve.He valve was leak tested; leaked from the damaged silicone housing.The complaint is confirmed.The root cause for the issue reported by the customer is probably due to the leakage noted during the investigation.The root cause for the leakage noted during the investigation is 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 CLYNDRICAL W PRECHA
• 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: 16416764
• Report Number: 3013886523-2023-00048
• Device Sequence Number: 16976029
• Product Code: JXG
• UDI-Device Identifier: 10381780519133
• UDI-Public: (01)10381780519133(17)270531(10)6498231
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 823110
• Device Catalogue Number: 823110
• Device Lot Number: 6498231
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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