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 Obstruction of Flow (2423)

Patient Problems Cerebral Ventriculomeglia (2133); Confusion/ Disorientation (2553)

Event Date 06/20/2021

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: 3013886523-2021-00295.A physician reported that the certas valve was implanted to a (b)(6) year-old female patient via v-p shunt on (b)(6) 2021 with an unknown setting.On (b)(6) 2021, a shunt contrast was performed because the patient presented with disorientation and ventricular enlargement was confirmed.Obstruction was confirmed using a contrast medium, distribution was confirmed up to the inside of the valve, and there was a possibility of obstruction at the sg site and the distal catheter site.On (b)(6) 2021, the valve and bactiseal catheter (823073, serial (b)(4)) were revised, but not replaced.The physician tried to replace the shunt; however, it was found that the abdominal catheter was not placed properly.The same one was placed again.

Event Description

N/a.

Manufacturer Narrative

The certas valve (828814) was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.

• 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: 12140425
• MDR Text Key: 267672303
• Report Number: 3013886523-2021-00294
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: 5038060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR