MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MEDOS PROG INFANT VALVESYSTEM; CHPV

Catalog Number 823101

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2021

Event Type  malfunction  

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 a hakim programmable shunt valve was reportedly obstructed during surgery.No patient injury and no surgical delay reported.No further details were reported.

Event Description

N/a.

Manufacturer Narrative

The hakim valve was returned for evaluation: device history record (dhr)- lot 4235867, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; biological debris was noted.The position of the cam when valve was received was 110mmh2o.The valve was hydrated.The valve was tested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The valve was leak tested and no leaks noted.-the catheters were irrigated no occlusions were noted.The valve failed the test for reflux and pressure.The valve was flushed the valve passed the test.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 dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the ruby ball, on the seat of ruby ball and on the cam mechanism.The cam magnets were controlled and passed.The root cause for the programing and pressure issues noted during investigation is 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 could have been due to biological debris and protein build up, but at the time of investigation no occlusion was noted.

• Brand Name: MEDOS PROG INFANT VALVESYSTEM
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11357477
• MDR Text Key: 232803297
• Report Number: 3013886523-2021-00082
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 823101
• Device Lot Number: 4235867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR