MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Catalog Number 828800PL

Device Problems Infusion or Flow Problem (2964); Material Integrity Problem (2978)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The certas valve was received for evaluation.Unique device identifier (udi) (b)(4).Review of the history device records for the product code 82-8800pl with lot 4837631 conformed to the specifications when released to stock failure analysis - the valve was visually inspected; the silicone housing was cut/torn in the needle chamber.The position of the cam when valve was received was at setting 4.The valve was hydrated.The valve was leak tested and leaked from the cut/tear in the needle chamber.The valve passed the test for programming, occlusion, refux and pressure.The root cause for the problem reported by the customer is due to the cut/tear in the silicone housing in the needle chamber 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.

Event Description

A facility reported a tear in a shunt reservoir.A certas plus inline valve was implanted in a patient via a ventricular peritoneal shunt on (b)(6) 2020.The valve was implanted and was being tested for function and patency, before closing, when there was no flow distally and a tear was noted in the reservoir by the surgeon and a leak was discovered.There surgical case was prolonged by an estimated 30%, and the patient received an additional 20-25 minutes of anesthesia while the surgeon swapped out the damaged valve with a new valve.The patient¿s outcome was not compromised since the issue was discovered prior to closing.A medwatch report form (b)(4) was received stating that the certas valve is broken and a hole was noted by the surgeon during surgery.A new implant was placed after the issue noted.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Type of Device: CERTAS PLUS
• 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: 11389699
• MDR Text Key: 238137073
• Report Number: 3013886523-2021-00094
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828800PL
• Device Lot Number: 4837631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• 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
• Patient Age: 49 YR