MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG UTZ BAC CATH ACC; DEFAULT

Catalog Number	828817PL
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported a certas valve (unknown product id) had no flow, therefore, a ventriculoperitoneal (vp) shunt revision was performed.No additional information was provided after several attempts.
Additional Manufacturer Narrative
The suspected certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected and a needle hole was noted in the chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested and the leak tested passed; but only leaked from the needle hole in the needle chamber.Root cause analysis - it was determined that the possible root cause for the issue reported by the customer could have been due to after steam sterilization the ruby ball stuck to the ruby seat and potential effects of failure include ¿excessive pressure required to flush the valve pre-procedure (valve popping)¿.However, at the time of investigation, no functional issues were noted.

• Brand Name: CRTS SM IL SG UTZ BAC CATH ACC
• Common Device Name: DEFAULT
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19217747
• Report Number: 3013886523-2024-00128
• Device Sequence Number: 8138898
• Product Code: JXG
• UDI-Device Identifier: 10381780529255
• UDI-Public: 10381780529255
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828817PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown