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 Insufficient Flow or Under Infusion (2182)

Patient Problem Injury (2348)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a insufficient flow of certas valve.The valve was implanted on (b)(6) 2020 and on (b)(6), insufficient flow was observed; therefore, it was replaced on (b)(6) 2020.

Manufacturer Narrative

Unique device identification (udi) - (b)(4).The certas valve was returned for evaluation: device history record was not possible as the lot number and was unknown.Failure analysis - the valve was visually inspected, needle hole in the needle chamber was noted.The valve was hydrated.The valve passed the test for programming, flushed, leak, reflux, siphon guard and pressure.The possible root cause for the problem reported by the customer could be due to "after steam sterilization the ruby ball sticks to the ruby seat¿ and potential effects of failure include ¿'excessive pressure required to flush the valve pre-procedure, no functional issues were noted during the investigation.

• 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: 10380148
• MDR Text Key: 202066669
• Report Number: 3013886523-2020-00034
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 MO