MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Obstruction of Flow (2423)

Patient Problem Dizziness (2194)

Event Date 06/25/2021

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 plus programmable in-line valve was implanted in a patient on (b)(6) 2021.When both the shunt and peritoneal catheter were integrated, the cerebral spinal fluid did not drip at all.After disconnecting the certas shunt and bactiseal peritoneal catheter, both were functioning well individually.The surgeon chose to close the surgery and observe.The obstruction was observed both during and after implantation.The surgeon did not observe signs or symptoms of clinical improvement in the patient post implantation and the patient experienced giddiness.The timeframe between implantation and onset of signs and symptoms was 2 days.The patient was taken to the operating room and the shunt was explanted on (b)(6) 2021.The patient was discharged from the hospital 2 days after the shunt was explanted.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The certas valve was returned for evaluation.Device history record (dhr) - product code 828804 with lot 5255515 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; no defects were noted.The valve was hydrated.The valve was leak tested and only leaked from needle holes noted.The valve passed the test for programming, occlusion, reflux, siphon guard 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 possible root cause for the issue reported by the customer ¿before implant¿ could have been due to 'excessive pressure required to flush the valve pre-procedure ("valve popping"), at the time of investigation no occlusion issues were noted.The possible root cause for the issue reported by the customer ¿after implant¿ could be due to biological debris and protein build up interfering with the valve, at the time of investigation the no occlusion issues were noted with the valve.

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• 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: 12170785
• MDR Text Key: 261709040
• Report Number: 3013886523-2021-00303
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Device Lot Number: 5255515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1