MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 07/19/2021

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 physician reported a certas valve was implanted to a (b)(6) male patient via l-p shunt on (b)(6) 2021 with an unknown setting.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).The cerebrospinal fluid was flowing after the operation however, there was a suspicion of obstruction from around (b)(6)2021, and the valve was removed and replaced on (b)(6) 2021.It is unknown if the patient experienced any signs and symptoms.The patient is in follow up.

Event Description

N/a.

Manufacturer Narrative

The certas valve was retuned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 1.The valve was visually inspected; biological debris was noted (tainted the inside of the valve mechanism casing, as well as needle holes in the needle chamber.The valve was hydrated.The valve was tested for programming and passed the test for all settings, rc position not visible.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for 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 could be due to biological debris and protein build up interfering with the valve, at the time of investigation the no functional issues were noted with the valve.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• 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: 12290973
• MDR Text Key: 265592579
• Report Number: 3013886523-2021-00348
• 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,health professional
• 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: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR