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

Catalog Number 828810PL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 12/15/2021

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

1 of 2 reports.Other mfg report number: 3013886523-2020-00300.A physician reported a certas plus small valve and bactiseal catheters were implanted on a 4-month female patient on (b)(6) 2020 for the treatment of hydrocephalus.On (b)(6) 2020, the patient had to be taken back to surgery for a shunt revision because the patients¿ symptoms of increased head circumference and bulging fontanel.Patient condition was decreasing prior to surgery for revision.The certas plus small valve only was replaced by another certas plus small valve only (828810pl lot# 4940607) and the bactiseal peritoneal catheter was replaced by a bactiseal barium stripe distal catheter (ns0339 lot# 4963361).

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The valve was returned for evaluation: device history record (dhr)- lot 4755552, conformed to the specifications when released to stock.Failure analysis- the valve was visually inspected; no defects were noted.The position of the cam when valve was received was at setting 3.The valve passed the test for progrmming, flushing, leaking, reflux 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 to biological debris and protein build up interfering with the valve mechanism, no occlusion issues were noted during the investigation.

• 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: 11120861
• MDR Text Key: 225280574
• Report Number: 3013886523-2020-00299
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828810PL
• Device Lot Number: 47555552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 4 MO