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

Catalog Number	823162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
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
The physician reported a hakim valve (id (b)(6)) was implanted via ventriculoperitoneal (vp) shunt due to congenital hydrocephalus on an unknown date with unknown setting.On (b)(6) 2024, a revision surgery was performed to remove the valve due to obstruction.The patient's primary disease is myelomeningocele.The patient is under follow-up.According to information provided, it is unknown if the patient experienced any signs and symptoms due to obstruction.It is also unknown how the obstruction was discovered and if the valve was replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - product code 82-3162 with lot 5056584, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the silicon housing of the needle chamber was damaged.The position of the cam when valve was received was 130mmh2o.The valve passed the test for programming, occlusion, and reflux.The valve was leak tested; it failed and leaked from the damaged silicone housing in the needle chamber.The siphon guard and pressure test were not possible due to the damaged silicone housing.Root cause analysis - no root cause could be determined for the ¿obstruction¿ issue reported by the customer as the technician could not confirm an occlusion with the valve at the time of investigation.A possible root cause for the issue reported by the customer could be due to the damaged silicone housing in the needle chamber (leakage into unintended parts of the body instead of going through the valve).The root cause of the damaged silicone housing noted during the investigation 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.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19493954
• Report Number: 3013886523-2024-00164
• Device Sequence Number: 8500650
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)250930(10)5056584
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 08/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 823162
• Device Lot Number: 5056584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male