MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE; CHPV

Catalog Number 823834

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

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 that after inserting both ventricular and peritoneal catheters and connected to the valve, the surgeon pumped the reservoir to flush the valve and be sure there is fluid at the end tip of peritoneal catheter and the valve seemed blocked, the reservoir was stiff and no fluid from the peritoneal end tip.He decided to change valve.The event led to 2 hours surgical delay.

Manufacturer Narrative

The hakim valve was returned for evaluation: dhr - lot 5321745 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects noted.The position of the cam when valve was received was 110mmh2o.The valve was hydrated.The valve passed the tests for programming, occlusion, leaks, reflux and pressure.Root cause - 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 valve seemed blocked could be due to users¿ error, at the time of investigation no occlusion was noted with the valve.

• Brand Name: PROG VALVE INLINE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12104859
• MDR Text Key: 259653101
• Report Number: 3013886523-2021-00281
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 823834
• Device Lot Number: 5321745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1