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

Model Number	823110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Decreased Level of Consciousness (4591)
Date of Event	11/05/2022
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
1 of 2 reports (same patient, different valves).Other mfg report number: 3013886523-2022-00580.A facility reported a hakim valve was implanted on (b)(6) 2022 in a 58 year old male patient.It did not function properly and was replaced on (b)(6) 2022 with a new valve (id 823110).The second valve presented with the same failure and was explanted on (b)(6) 2022.It seems that there were some debris in the valves.Consequences for the patient: drop in consciousness, longer hospital stay.The patient status is: recovered.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation; dhr - lot 5679519, conformed to the specifications when released to stock failure analysis - the valve was visually inspected: small cuts/tears/holes were noted near the needle guard.The valve was leak tested - failed, leaked from the small cuts/tears/holes were noted near the needle guard.The valve passed the tests for programming, occlusion and pressure.No root cause could be determined for the issue reported by the customer as the technician could not confirm any yellowish build up on distal end, only slight yellow discoloring, this did not effect the functioning of the valve.The root cause for ¿small cuts/tears/holes that were noted near the needle guard.¿ is probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The possible root cause for the ¿failed due to yellowish build up on distal end of valve,¿ noted by the customer could have been due to ¿small cuts/tears/holes that were noted near the needle guard.¿.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16022838
• Report Number: 3013886523-2022-00579
• Device Sequence Number: 14923537
• Product Code: JXG
• UDI-Device Identifier: 10381780519133
• UDI-Public: (01)10381780519133(17)260630(10)5679519
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/15/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 823110
• Device Catalogue Number: 823110
• Device Lot Number: 5679519
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: 58 YR
• Patient Sex: Male