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

Catalog Number 828806

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 12/14/2021

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 via l-p shunt on (b)(6) 2021, with setting 7.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2021, the setting pressure was changed from 7 to 6.On an unknown day, the physician tried to change the set pressure because the patient's consciousness was not clear, but the set pressure could not be changed.On (b)(6), the physician tried to puncture the valve but couldn¿t, and the physician couldn't get the cerebrospinal fluid.It was suspected shunt dysfunction, therefore, the valve was removed and replaced on (b)(6) 2021.

Event Description

N/a.

Manufacturer Narrative

The certas valve (id (b)(4) was returned for evaluation.Device history record (dhr) - the product code 828806 with lot 5355139 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 7.The valve was visually inspected, small needle hole noted in the underside of the needle chamber, small cut in ventricular catheter near the suture was noted.The valve was hydrated.The valve was leak tested only leaked from the small needle hole in the underside of the needle chamber and leaked from the cut in the catheter.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 root cause for the cut in the catheter is probably due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu silicone has a low cut/tear resistance.The possible root cause for the issue reported by the customer could have been due to biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no programing issues were noted.

• 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
• 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: 13117030
• MDR Text Key: 282954502
• Report Number: 3013886523-2021-00574
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Device Lot Number: 5355139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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