MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 823100

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 05/20/2021

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 an occluded shunt valve.A codman hakim programmable valve was implanted in a patient via ventricular peritoneal shunt on an unknown date with an unknown setting.On an unknown date, obstruction was suspected; the patient was symptomatic, but symptoms were not provided.On (b)(6) 2021, the patient was taken to the operating room for a revision surgery where the valve was removed and replaced.The patient is in the follow up.

Manufacturer Narrative

The hakim valve was returned for evaluation.Device history record (dhr) - the product code 82-3100 with lot cklbml, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; needle holes in the silicone housing were noted.The position of the cam when valve was received was 80mmh2o.The valve was hydrated.The valve was leak tested and only leaked from the needle holes.The catheters were irrigated, no occlusions noted.The valve passed the test for programming, occlusion, reflux and pressure.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 mechanism, at the time of investigation no functional issues were noted.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11956738
• MDR Text Key: 255766093
• Report Number: 3013886523-2021-00251
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 823100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1