MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Infusion or Flow Problem (2964)

Patient Problem Obstruction/Occlusion (2422)

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 physician reported that the certas inlin valve (product id 828806) was implanted via v-p shunt (unknown date and setting).On an unknown date, underdrainage was found, and obstruction of the valve was suspected.Therefore, the valve was replaced with a new one.During the replacement, the patency of the ventricular catheter was confirmed, so the ventricular catheter remained, and the valve with the peritoneal catheter was replaced.After the procedure, it was confirmed that the distal side from the valve was obstructed.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The valve and catheter were returned for evaluation.Failure analysis - the valve was visually inspected; a cut/torn was noted in the silicone housing just after the proximal connector and needle holes were also noted in the needle chamber.The position of the cam when valve was received was at setting 2.No occlusion and leakage noted in the catheter.The valve was hydrated.The valve was leak tested and failed, a leakage was noted from the cut/torn in the silicone housing just after the proximal connector.The valve was then pressure tested and failed the test due to the cut/torn in the silicone housing just after the proximal connector.The valve passed the test for programming, occlusion, refux and siphon guard.The root cause for the problem reported by the customer is due to the cut/torn in the silicone housing just after the proximal connector that was probably caused by a sharp or pointed object coming into contact with the silicone housing.As specified in the "ifu": "silicone has a low cut and tear resistance; therefore, exercise care when placing ligatures [.].Do not use sharp instruments when handling the silicone valve or catheters; use shod forceps.Cuts or abrasions from sharp instruments might rupture or tear the silicone components".

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• 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: 11096665
• MDR Text Key: 224425226
• Report Number: 3013886523-2020-00284
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1