MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Catalog Number 823842

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebral Ventriculomeglia (2133)

Event Date 07/06/2021

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 physician reported a hakim valve was implanted on a (b)(6) female patient via l-p shunt on (b)(6) 2021 with an unknown setting.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2021, ventricular enlargement was observed on imaging, and flushing and pumping did not improve the symptoms.The valve was removed and replaced on (b)(6) 2021.

Manufacturer Narrative

The valve was returned for evaluation: device history record (dhr): lot 3841198 conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; it was noted a slight cut/tear in the silicone around the proximal connector.The position of the cam when valve was received was at 70mm h2o.The valve was hydrated.The valve was leak tested only leaked from the cut/torn in the silicone housing around the proximal connector.The valve passed the test for programming, occlusion, anti-reflux, siphon guard and pressure.The received catheters were irrigated; no occlusion was noted.The received catheters were leak tested; no leakage was noted.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 "clogged" reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism.But, at the time of investigation, no occlusion was noted.

Event Description

N/a.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12250444
• MDR Text Key: 264265679
• Report Number: 3013886523-2021-00341
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 823842
• Device Lot Number: 3841198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR