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

Catalog Number 823182

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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 Description

A facility reported that they think the shunt was blocked due to debris and was explanted on (b)(6) 2021.The implantation date was (b)(6) 2021 in a patient with meningitis.

Manufacturer Narrative

The hakim valve was returned for evaluation: dhr - lot number 4928238, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted.The valve was tested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The valve passed the tests for occlusion, reflux and cam magnets.The valve was leak tested: only leaked from the needle holes in the needle chamber.The silicone was cut just after valve casing.The cam mechanism was gently moved.The valve was retested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The valve was then pressure tested at setting 100mmh20, the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, and on the base plate.The root cause for the programing issue noted during the investigation was due to biological debris and protein build up found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, and on the base plate.The possible root cause for the occlusion issue reported by the customer was probably due to biological debris and protein build up found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, and on the base plate, at the time of investigation no occlusion was noted.

Event Description

N/a.

• Brand Name: PROG VALVE RIGHT ANGLE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12104805
• MDR Text Key: 259653418
• Report Number: 3013886523-2021-00277
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823182
• Device Lot Number: 6928238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1