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

Catalog Number	828814PL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2024
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
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2024-00163.A facility reported a patient who experienced a fall at home.The patient had been using a certas valve (id (b)(6)) before the fall.The valve malfunctioned and resulted in revision surgery on (b)(6) 2024.It was removed and replaced with the certas valve (id (b)(6)).On (b)(6) 2024, the patient was discharged.On (b)(6) 2024, the patient went to the emergency room (er) due to a fluid accumulation under the incision around the valve.The customer described as it had snapped.A revision surgery was performed on the same day, and it was found that the shunt was broken.The valve was removed along with all its broken parts.After replacing the valve, a computed tomography (ct) scan was performed to verify that the new one was in place and operating properly.With no concerns, the patient is now at home and is in stable condition.
Additional Manufacturer Narrative
The certas valve (id 828814pl) was returned for evaluation.Device history record (dhr) - the product code 82-8814pl with lot 7351438, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected, the siphon guard damaged.A cut marks were noted on the housing and on the siphon guard.Root cause analysis - the root cause for the issue reported by the customer, is due to improper handling of the device in view of the cut marks on siphon guard.

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA W/SG
• 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: 19487678
• Report Number: 3013886523-2024-00161
• Device Sequence Number: 20605345
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: (01)10381780529378(17)281231(10)7351438
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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: 828814PL
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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 Age: 3 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White