MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Separation Problem (4043)

Patient Problem Injury (2348)

Event Date 06/21/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that the certas valve was separated at the junction of siphonguard and chamber of the valve.The valve was explanted on (b)(6) 2020 and the issue was identified.The valve was replaced.

Manufacturer Narrative

Updated fields: g4, d4, g7, h2, h3, h4, h6, h10.Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided and showed 2 nr-reports when released to stock on the 12th december 2019.The nr report issues have no link to this complaint.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for the issue reported by the customer could be due to a sharp or pointed object coming into contact with the silicone housing as noted in the ifu silicone has a low tear/cut resistance.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation.Failure analysis - the valve was visually inspected.The silicone housing was cut/torn around the siphon guard, marks were noted in the siphon guard.Biological debris was noted near siphon guard and needle holes were noted in the needle chamber.The valve could not be leak tested due to the damaged silicone housing and could not be reflux tested due to the damaged silicone housing.The catheter was irrigated, no occlusion was noted.The valve passed the test for programming, occlusion, siphon guard and pressure.The root cause for the problem reported by the customer is due to the cut/tear in the silicone housing around the siphon guard this was probably caused by a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the marks noted in the siphon guard are due to a sharp or pointed object coming into contact with the siphon guard.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10346054
• MDR Text Key: 201524782
• Report Number: 3013886523-2020-00021
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

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: 828804
• Device Lot Number: 4191102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 09/11/2020; 12/16/2020
• Supplement Dates FDA Received: 09/29/2020; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1