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

Catalog Number 823100

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 11/03/2020

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 an obstructed hakim valve.The valve was implanted on (b)(6) 2020.The patient symptoms of hydrocephalus did not improve, and the valve was explanted, and replaced on (b)(6) 2020.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The hakim valve was returned for evaluation.Device history record (dhr) - lot 4171051, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; biological debris was noted inside valve and on the outside of the valve, biological debris was also noted inside of catheters.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial number (b)(6) and programmer 82-3190 with serial number (b)(6), the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed and failed.The catheters were irrigated, failed the catheters were occluded with biological debris.The valve could not be reflux due to occlusion.The valve was dismantled and was examined under microscope at appropriate magnification and biological debris was found covering the valve mechanism and inside the catheters.The cam magnets were controlled and passed.The root cause for the issue reported by the customer is due to biological debris found covering the valve mechanism and inside the catheters.

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: 11027125
• MDR Text Key: 222021828
• Report Number: 3013886523-2020-00252
• 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
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1