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

Catalog Number 828806

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/22/2021

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 a drainage issue with a shunt valve.A certas plus programmable valve was implanted in a patient via ventricular peritoneal shunt in (b)(6) 2019 with an initial setting of the patient complained of gait disturbance in (b)(6) 2021 and visited the hospital.Although the pressure setting was able to change, the patient's clinical symptoms did not improve.An imaging study with contrast was performed later, and the contrast from the ruby ball to the distal side could not be confirmed.The patient was brought to the operating room for a revision surgery, the valve was removed and replaced on (b)(6) 2021.No further information was provided by hospital.

Manufacturer Narrative

The certas valve was returned for evaluation: failure analysis: the valve was visually inspected; the needle guard was raised, as well as needle holes in the needle chamber.The position of the cam when valve was received was at setting 3.The valve passed the test for programming, flushing, siphon guard, reflux and pressure.The valve was leak tested, only leaked from the needle holes in the needle chamber.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.Root cause: the possible root cause for the issue reported by the customer is probably due to wrong handling as noted in the instructions for use (ifu): do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of the investigation no occlusion was noted.

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: 11606471
• MDR Text Key: 256244315
• Report Number: 3013886523-2021-00156
• 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
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• 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: 04/23/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR