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 Problem Failure of Implant (1924)

Event Date 07/02/2021

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

A physician reported a certas valve was implanted on (b)(6) 2021 with setting 3.After implantation, the valve was functioning properly.The patient returned the next day because the valve was malfunctioning (not draining).Csf was clear, so no apparent obstruction was observed.The valve was removed and replaced.

Manufacturer Narrative

Unique device identification (udi): (b)(4) or (b)(4).The certas valve was not returned for evaluation and no lot number information has been provided.Therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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: 12217159
• MDR Text Key: 263121592
• Report Number: 3013886523-2021-00318
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814PL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1