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

Catalog Number 828810PL

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Nausea (1970); Injury (2348)

Event Date 12/17/2020

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 the certas plus small was implanted to a (b)(6)-year-old patient on (b)(6) 2020 with a setting of 5.It worked at setting 5 for two days.Then the patient started to have headache and nausea, and it was dialed up to setting 7.The patient continued to have symptoms, so a nuclear shunt study was completed which showed free flow of fluid through the shunt system despite the icp being only 4 to -30.Once partially explanted, in vivo testing showed that despite at setting 7 (high pressure) fluid freely flowed through the peritoneal catheter at a high rate without stopping (patient at 0 level).The valve was explanted on (b)(6) 2020 and a bactiseal evd catheter was placed.A competitor¿s valve was placed on (b)(6) 2020.

Manufacturer Narrative

The valve was returned for evaluation.Review of the device history records was not possible as the lot number was unknown.Unique device identifier (udi): (b)(4).Unique device identifier (udi): (b)(4).Failure analysis - the valve was visually inspected, no defects were noted.The position of the cam when valve was received was at setting 7.The catheters were irrigated; no occlusions noted.The catheters were leak tested; no leakage was noted.The valve passed the test for programming, leak, occlusion, ref; ux, 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.

Event Description

N/a.

• Brand Name: CRTS SM IL VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11127890
• MDR Text Key: 225515280
• Report Number: 3013886523-2021-00002
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828810PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1