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

Catalog Number 828806

Device Problem Positioning Problem (3009)

Patient Problems Ventricle, Abnormality Of (2078); Injury (2348)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported difficulty changing the setting of a certas plus: the valve was implanted via v-p shunt on (b)(6) 2020 with setting 2.However, when the physician tried to change to setting to 1, it was not possible.As a result, the patient developed ventricular enlargement and on (b)(6) 2020, the valve was replaced with a new one.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h6, h10 the certas valve was returned for evaluation.Device history record - review of the history device records for the valve, product code 82-8806 was not possible as the lot number was unknown failure analysis - the valve was visually inspected, no defects noted.The valve was leak tested; only leaked from the needle holes in the needle chamber.The valve passed the test for programming, occlusion, siphon guard, reflux and pressure.No root cause could be determined as the technician could not confirm the problem reported by the customer at the time of investigation.The possible root cause for the problem reported by the customer could be due to "biological debris and protein build up, no programming or occlusion issues were noted during the investigation.

• 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: 10280844
• MDR Text Key: 202690459
• Report Number: 1226348-2020-00286
• 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
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 06/24/2020
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR