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

Catalog Number 828814PL

Device Problem Infusion or Flow Problem (2964)

Patient Problems Vomiting (2144); Irritability (2421)

Event Date 07/24/2020

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

5 of 5 reports - other mfg reports: 1226348-2020-00251, 3013886523-2020-00048, 3013886523-2020-00049, 3013886523-2020-00050.A physician reported obstruction of a certas valve: patient's initials: (b)(6).Date of implant: (b)(6) 2019 at woman¿s hospital date of explant: (b)(6) 2020.Valve malfunction: normal csf flow from ventricular catheter and normal distal runoff when distal tubing tested with manometer.Valve was tested on the back table after the procedure, obviously occluded.Date of malfunction: (b)(6) 2020.Issue discovery: after implantation.Signs/symptoms of malfunction: poor po intake, vomiting, altered mental status, irritability, enlarged ventricles on imaging, subcutaneous fluid around hardware.Delay in procedure: no.Present patient condition: recovered to baseline.Additional information: priming was performed successfully prior to valve insertion.The medical staff successfully changed the valve settings prior to the revision surgery, no patient improvement; therefore it was replaced.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation: review of the history device records conformed to the specifications when released to stock failure analysis - the valve was visually inspected, needle holes noted in the needle chamber.The position of the cam when the valve was received was at setting 1.The valve was hydrated.The valve was leak tested and only leaked from the needle holes 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 or catheter at the time of investigation.The possible root cause for the problem reported by the customer could be due to: the choroid plexus or plica choroidal, is a plexus of cells that arises from the tela choroidea in each of the ventricles of the brain, and was interfering with the valve mechanism.

• Brand Name: CRTS SM IL 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: 10432000
• MDR Text Key: 204184262
• Report Number: 3013886523-2020-00047
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814PL
• Device Lot Number: 4131169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1