MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV W CATH ACC; INTERNAL CSF DRAINAGE

Catalog Number	828825PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
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 (id 828825pl) was implanted in an unknown date.A week later it was explanted because the patient had some issues.The valve was set at setting 8 to virtually turn it off.No additional information was provided after several attempts.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The certas valve (id 828825l) was returned for evaluation.Device history record (dhr) - the product code 82-8825pl with lot 7565484 conformed to specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 8.The valve was visually inspected; biological debris were observed inside the valve, and the siphon guard was broken.The valve passed the test for programming and pressure.The valve failed for occlusion and leak due to a leaked from the siphon guard.The siphon guard was removed and was observed under microscope: cut marks noted on the sg.Root cause analysis -the roots cause for the leakage issue is due to human misuse, as noted in ifu: silicone has a low cut and tear resistance.Do not use sharp instruments when handling the silicone valve or catheter.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.Do not fold or bend the valve during insertion.Incorrect insertion may cause rupture of the silicone housing.The possible root cause for the reported issue could be due to biologicals debris.As noted in ifu: accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.

• Brand Name: CRTS RA SG VLV W CATH ACC
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24647787
• Report Number: 3013886523-2026-00061
• Device Sequence Number: 9842142
• Product Code: JXG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828825PL
• Device Lot Number: 7565484
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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: Male