MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE W/SPHNGD/BAC CAT; CERTAS PLUS W/ BACTISEAL & SG

Catalog Number 828807

Device Problem Improper Flow or Infusion (2954)

Patient Problem Injury (2348)

Event Date 12/10/2020

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 the cerebrospinal fluid was not flowing through a certas valve after being implanted with setting 1.The valve was replaced with a competitor's valve on (b)(6) 2020.The underlying patient's medical condition was ivh (intraventricular hemorrhage) and hydrocephalus.The patient started to slowly deteriorate on (b)(6) 2020 from the valve malfunction.

Manufacturer Narrative

Udi: (b)(4).The certas valve was returned for evaluation: failure analysis - the valve was visually inspected, no defects were noted.The valve passed the test for programming, occlusion, leak, siphon guard.The valve failed the test for reflux, pressure.The valve was dismantled and images were taken at appropriate magnification: biological debris were noted on the flat spring of cam/ball and on the ruby ball.The root cause for the reflux and pressure problems noted during the investigation was due to biological debris on the flat spring of cam/ball and on the ruby ball, the debris was stopping the ruby ball from sitting correctly on the seat of the ruby ball.The possible root cause for the issue reported by the customer "csf did not flow through certas valve" was probably due to biological debris and protein buildup interfering with the valve mechanism.

Event Description

N/a.

• Brand Name: CERTAS INLINE W/SPHNGD/BAC CAT
• Type of Device: CERTAS PLUS W/ BACTISEAL & SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11289847
• MDR Text Key: 230691505
• Report Number: 3013886523-2021-00061
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828807
• Device Lot Number: 10886704071396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO