MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTS INLIN VLV W/UNIT BAC CAT; CERTAS PLUS W/ BACTISEAL

Catalog Number 828803

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

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 a certas plus unitized valve with bactiseal catheter was implanted on a female patient during the first week of december with an initial pressure level 4, then lowered to 3.A week and a half after implantation, she had a ct scan, and everything was fine.Another ct scan was performed on (b)(6) 2020, and air was found in both the head and abdomen.The doctor confirmed that the pre-implantation priming was performed.The doctors are now trying to understand if there is a pneumocephalus.The patient has no symptoms and the valve is still in place.After detecting air both in head and abdomen, they closed the valve.A subsequent head ct scan reveals less air in the ventricles (much less than previous week), and the medical team chooses to re-open the valve.The patient is ataxic but can stand up and walk.The medical team idea is that there is no valve mechanism failure.

Manufacturer Narrative

Udi: (b)(4).The complaint sample was not returned (still implanted at this time), therefore an evaluation of the device could not be performed.The cause(s) of the difficulty reported by the customer could not be determined.As stated by medical safety specialist, the most possible root cause for ¿air in the abdomen and that air could go up through the valve system into the ventricles¿ could be linked to patient's condition (¿defecation difficulties or cough persistence¿).

Event Description

N/a.

• Brand Name: CERTS INLIN VLV W/UNIT BAC CAT
• Type of Device: CERTAS PLUS W/ BACTISEAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11127790
• MDR Text Key: 225506606
• Report Number: 3013886523-2021-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1