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

Catalog Number 828804

Device Problem Infusion or Flow Problem (2964)

Patient Problems Ventricle, Abnormality Of (2078); Obstruction/Occlusion (2422)

Event Date 12/14/2020

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 facility reported that the certas inlin valve was implanted on (b)(6) 2020 to a patient via v-p shunt on unknown date with setting 5.However, on (b)(6) 2020, ventricular enlargement was observed under mri without any clinical symptoms.The physician suspected valve obstruction.Therefore, the valve will be replaced to a new one (828800) on (b)(6) 2020.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; the needle guard was raised and needle holes in the needle chamber were noted.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 housing base.The root cause for the problem reported by the customer is due to the raised needle guard this 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.

• 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
• MDR Report Key: 11097556
• MDR Text Key: 224522904
• Report Number: 3013886523-2020-00292
• 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,u
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 01/18/2021
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR