MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR IN LINE PRECISION VAVLE SG MH; PRECISION VALVES WITH SG

Catalog Number 825464

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

Patient Problem Failure of Implant (1924)

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

1 of 2 reports.Other mfg report number: 3013886523-2021-00285.A facility reported that two precision valves were explanted because they are not working.Additional information has been requested.

Manufacturer Narrative

Valve was returned for evaluation: device history record (dhr) - the product code 82-5464 with lot 4434214, conformed to the specifications when released to stock.Failure analysis - the valve is a precision valve with 4 dots.The valve was visually inspected: a cut/tear was noted in the silicone housing around the siphon guard, also marks were noted on the siphon guard.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for occlusion, reflux, siphon guard and pressure.The possible root cause for the issue reported by the customer, could be due to the cut/tear in the silicone housing.The root cause for the cut/tear and marks in the silicone housing and siphon guard, is probably due to a sharp or pointed object coming into contact with the silicone housing and siphon guard, as noted in the ifu silicone has a low tear/cut resistance.

Event Description

N/a.

• Brand Name: IN LINE PRECISION VAVLE SG MH
• Type of Device: PRECISION VALVES WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12125260
• MDR Text Key: 264476437
• Report Number: 3013886523-2021-00284
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 825464
• Device Lot Number: 4434214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1