MAUDE Adverse Event Report: VASORUM LTD. CELT ACD PLUS VASCULAR CLOSURE DEVICE

Model Number	CLT-06
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint an attempt was made to obtain complete event information.A search of the complaint files was completed, and no other complaints were identified with the same lot number.A review of the lot records did not identify any non-conformances or issues during the production of this particular lot.The device is being returned to vasorum ltd.Vasorum ltd have not yet received the device for examination.The implant was not implanted, and the patient was reported as stable post procedure.All available information has been placed on file in the customer complaint files of vasorum ltd.For appropriate tracking, trending and follow-up.This report is the initial report being submitted by vasorum ltd.
Event or Problem Description
It was reported that a physician deployed step one and two, attempted to eject the implant and the clip wouldn't detach after the lever was pushed.The delivery system and the implant was pulled out and manual pressure applied, followed by femstop application.Hemostasis was achieved.The device is being returned to vasorum ltd for inspection.
Event or Problem Description
It was reported that the physician deployed step one and two of a celt acd plus 6f device and attempted to eject the implant and the clip wouldn't detach after the lever was pushed.The delivery system and the implant was pulled out and manual pressure applied, followed by femstop application.Hemostasis was achieved.The patient was reported as stable post procedure.No health consequences or permanent impairment or damage.
Additional Manufacturer Narrative
During the processing of this complaint, attempts were made to obtain complete event information.The implant was explanted, and the patient was reported to be stable post-procedure.A search of the complaint files was completed, and no other complaints were identified involving the same lot number.The device was returned to vasorum ltd for examination by the r&d department and subsequently by the subcontract manufacturer under vasorum ltd supplier non-conformance report, sncr 020.Root cause: based on the investigations performed by both the vasorum r&d department and the subcontract manufacturer, it is considered most likely that a device to which a lower tightening torque had been applied was erroneously processed further instead of being rejected.The subcontract manufacturer's investigation concluded that this was an isolated case.All corrective and preventive actions by the subcontract manufacturer have been completed as reported under sncr 020.All available information has been placed on file in the vasorum ltd customer complaint records for appropriate tracking, trending, and follow-up.This report is being submitted by vasorum ltd as a follow-up report.Investigation findings code 4247 was used as no other feasible code was found for definition: 'problems caused by incorrect adjustment of device components during manufacturing assembly'.

• Brand Name: CELT ACD PLUS VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD.; 2012 orchard avenue; citywest business campus; dublin, co. dublin D24WP W6; EI D24WPW6
• Manufacturer (Section G): VASORUM LTD.; 2012 orchard avenue; citywest business campus; dublin, co. dublin D24WP W6; EI D24WPW6
• Manufacturer Contact: 2012 orchard avenue; citywest business campus; dubln, co. dublin D24WP-W6
• MDR Report Key: 23817089
• Report Number: 3009984513-2025-00011
• Device Sequence Number: 15777816
• Product Code: MGB
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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 Model Number: CLT-06
• Device Lot Number: 943528
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male