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

Catalog Number 828804

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

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 the syphonguard disconnected from the valve (id (b)(4)) requiring revision surgery.

Manufacturer Narrative

The valve was received for evaluation: dhr - lot 5321028, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the siphon guard was disconnected from the valve.There is cuts/tears in the silicon housing and marks also noted in the siphon guard.The complaint was confirmed.Root cause - the root cause for the ¿cuts/tears in the silicon housing¿ are due a sharp or pointed object coming into contact with the valve, as noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.The root cause for the ¿marks noted in the siphon guard¿ are due a sharp or pointed object coming into contact with the valve.Additional information received: reason for surgical valve revision: deterioration of the patient's condition.Failure of the valve: on re-intervention, finding of leaky valve, damaged material, important effusion: since the initial implantation of the valve, has the valve be punctured: no.Date of implantation: (b)(6) 2022.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16592545
• MDR Text Key: 311780184
• Report Number: 3013886523-2023-00081
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780515845
• UDI-Public: (01)10381780515845(17)260131(10)5321028
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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: 5321028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1