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

Catalog Number 828814

Device Problem Infusion or Flow Problem (2964)

Patient Problems Vomiting (2144); Injury (2348)

Event Date 11/25/2020

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 physician reported that on (b)(6) 2020, the certas valve flow could not be confirmed and the patient was vomiting.The valve was implanted to the patient via arachnoid- peritoneal shunt on (b)(6) 2020 with initial setting 3.The patient's symptoms got better a but there was no change about ventricular size on x-ray.Five months after valve placement, the patient started vomiting.When the shunt contrast was performed, the flow could be confirmed only by high pressure.Therefore, the valve was replaced with a new one(hakim valve) on (b)(6) 2020.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The certas valve was returned for evaluation: device history record (dhr) - lot 4191136 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 2.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, reflux, 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 occlusion issues were noted.

• 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: 11042126
• MDR Text Key: 222641414
• Report Number: 3013886523-2020-00255
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814
• Device Lot Number: 4191136
• 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: 3 YR