MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number 828804PL

Device Problem Break (1069)

Patient Problem Cerebral Edema (4403)

Event Date 09/13/2021

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 facility reported a certas valve was implanted on (b)(6) 2020.Patient presented to neurosurgeon (b)(6) 2021 with sub-dermal fluid collection distal to valve.Symptom was swelling around areas of occipital skull and posterior cervical spine.Patient had previous surgery in the area of the cervical spine in (b)(6) 2021.The valve was explanted on (b)(6) 2021 and was found to be broken and separated at the juncture of the valve and siphonguard.It was determined that the cause of swelling was csf collection from disconnected valve.Patient developed csf hygroma in area of occipital skull and cervical spine.This required vp shunt revision and evacuation of csf.

Manufacturer Narrative

The certas valve was not returned for evaluation; however a photo was provided and evaluated: device history record (dhr) review: lot 4744436 conformed to the specifications when released to stock.Failure analysis: it was not possible to investigate the device as it was not returned for investigation.The complaint was confirmed with photo showing the siphon guard separated from the valve.The root cause for the issue reported by the customer "siphon guard broke off from valve housing" is probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low tear/cut resistance.

Event Description

N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• 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: 12545732
• MDR Text Key: 273738751
• Report Number: 3013886523-2021-00413
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 828804PL
• Device Lot Number: 4744436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Date Device Manufactured: 06/17/2020
• 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