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 Cerebral Ventriculomeglia (2133)

Event Date 07/16/2021

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) year-old female patient via v-p shunt on (b)(6) 2021 with setting 6.The patient had headache, imaging was performed and ventricular enlargement was confirmed on (b)(6) 2021.The set pressure was lowered, however, the hydrocephalus did not improved.The valve was removed and replaced on (b)(6) 2021.The device was used with ns9001(serial; unk).The patient is in the follow up.

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10 the certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated.The catheters were irrigated no occlusions noted, a cut/tear was noted in the ventricular catheter.The valve was leak tested and only leaked from the needle hole in the needle chamber.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 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.The root cause for the cut/tear in the ventricular catheter is probably due to wrong handling as noted in the ifu: silicon has a low cut/tear resistance.

• 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: 12290125
• MDR Text Key: 265578479
• Report Number: 3013886523-2021-00347
• 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

• 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: 08/04/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR