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

Catalog Number 828804

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cerebral Ventriculomeglia (2133); Ambulation Difficulties (2544)

Event Date 08/30/2021

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

1 of 2 reports.Other mfg report number: 3013886523-2021-00397.A physician reported a certas valve and a bactiseal catheter were implanted to a (b)(6) female due to subarachnoid hemorrhage (sah) via v-p shunt on (b)(6) 2021 with setting 5.Due to gait disturbance, shunt imaging was performed in (b)(6) and ventricular enlargement was confirmed.The ventricles did not shrink, and the set pressure was finally reduced to 2, but the ventricular size did not change.The patient is in the follow up.

Event Description

N/a.

Manufacturer Narrative

The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; the distal connector was squashed, and marks noted in the connector, and the needle guard was raised as well as needle holes in the needle chamber.The valve was hydrated.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.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.The root cause for ¿physicians commented that the connector at the distal end may have been damaged during placement¿ reported by the customer is probably due to user¿s error not using shod forceps, as noted in the ifu.The possible root cause for ¿the ventricles did not shrink, and the set pressure was finally reduced to 2, but the ventricular size did not change.¿ could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.The root cause for the raised needle guard noted during the investigation is probably due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of the investigation no functional issues were noted.

• 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
• 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: 12485704
• MDR Text Key: 271880440
• Report Number: 3013886523-2021-00396
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 91 YR
• Patient Sex: Female