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

Catalog Number 828816

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

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 that on (b)(6) 2021 the certas valve was implanted to a patient via v-p shunt with a setting of 1.After that, the setting was changed to 8 and underdrainage was observed.According to doctors, certas usually does not change the set pressures for mris below 3.0 tesla.However, the settings may have changed after the mri was taken on (b)(6).The valve was removed on (b)(6) 2021 and a revision surgery was performed.No further information was provided.

Event Description

N/a.

Manufacturer Narrative

The valve was returned for evaluation.Failure analysis - the valve was visually inspected; a needle hole was noted in the needle chamber.The position of the cam when valve was received was at setting 1.The valve was hydrated.The returned catheter was flushed and no occlusion was noted.The catheter was leak-tested and no leakage was noted.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 "underdrainage, blockage" could be due to biological debris and protein build up that may cause an occlusion.But, at the time of investigation, no programming or occlusion issues were noted.

• Brand Name: CRTS SM IL SG VLV UTZ CATH ACC
• 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: 11748306
• MDR Text Key: 249757251
• Report Number: 3013886523-2021-00191
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1