MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV UTZ CATH ACC; CERTAS PLUS SMALL & RA

Catalog Number 828812

Device Problem Infusion or Flow Problem (2964)

Patient Problem Loss of consciousness (2418)

Event Date 02/18/2021

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 that a certas valve was inserted into a (b)(6) patient for non-communicating hydrocephalus on (b)(6) 2021.Approximately 12 hours after the shunt placement the patient developed symptoms of shunt failure with a rapid fall in consciousness.A ct scan confirmed diagnosis and showed a significant increase in supratentorial ventricular size.On (b)(6) 2021, the shunt had to be removed because it was not working.The surgeon checked the shunt after removal and confirmed that the shunt did not work.Since it was the first time the surgeon used the product, the product specialist ensured there was not any obvious user errors and that there was an obstruction.It was not possible to pump the water through the shunt in a water bath after removal with the ventricle and atrial drain open.A secondary shunt surgery was not performed but the patient was treated with a successful third ventriculostomy after the noted shunt failure.The patient is now dismissed from the hospital to a rehab institution.She has no focal neurological deficits, but a moderate/small cognitive impairment applied by the shunt failure (amnesia for some previous incidents) but is gradually improving.The prognosis is probably considered favorable.

Manufacturer Narrative

The certas valve was returned for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects noted.The valve passed the tests for programming, occlusion, leak, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The root cause for the issue reported by the customer was probably due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no obstruction was noted.

• Brand Name: CRTS SM IL VLV UTZ CATH ACC
• Type of Device: CERTAS PLUS SMALL & RA
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11497733
• MDR Text Key: 247601072
• Report Number: 3013886523-2021-00117
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828812
• Device Lot Number: 4403266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR