MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE; CHPV

Catalog Number	823834
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports linked to mfg repot number 3013886523-2023-00434.A physician reported a hakim valve (id 823834) was implanted in 2019 via ventriculoperitoneal (vp) shunt with setting 90 mmh2o.The valve was used with the straight connector id (823053).On (b)(6) 2023, the valve setting was changed to 30 mmh2o.However, due to the result of patency check, the suspicion of blockage was confirmed.Therefore, the hakim valve and connector were removed and replaced on (b)(6) 2023.According to the information provided, it is unknown if the patient had signs and symptoms due to obstruction.
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
N/a.
Additional Manufacturer Narrative
Hakim valve (id 823834) was returned for evaluation.Device history record (dhr) - lot ctcbg6, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected, biological debris were noted in the housing and a needle hole in the needle chamber was noted.The valve passed the test for programming, occlusion and reflux.The valve passed the test for leak, only leak from the needle hole.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve device in view of the biological debris noted in the housing.

• Brand Name: PROG VALVE INLINE
• 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: 18301554
• Report Number: 3013886523-2023-00433
• Device Sequence Number: 7160715
• Product Code: JXG
• UDI-Device Identifier: 10886704041832
• UDI-Public: (01)10886704041832(17)200131(10)CTCBG6
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 03/06/2024

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: 01/31/2020
• Device Catalogue Number: 823834
• Device Lot Number: CTCBG6
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHUNT CONNECTOR TITANIUM STRL (ID 823053).
• Patient Age: 21 YR
• Patient Sex: Male