MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828824

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Injury (2348)

Event Date 11/15/2020

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 facility reported that the certas valve was not working.The valve was implanted on (b)(6) 2020.After six months, the physician confirmed the valve not working or the distal catheter is blocked.The patient was experiencing headache due to no drainage of the ventricular liquid since the implantation.On (b)(6) 2020 a surgery was planned to verify the function of the valve and the permeability of the catheters.Tha valve was changed.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The certas valve was returned for evaluation; device history record (dhr): conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; needle holes were noted 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, refux, 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 biological debris and protein buildup interfering with the valve mechanism, at the time of investigation, no functional issues were noted.

Event Description

N/a.

• Brand Name: CRTS RA SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10987762
• MDR Text Key: 220888831
• Report Number: 3013886523-2020-00238
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828824
• Device Lot Number: 3908784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR