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

Model Number	KCLT-06
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.A search of the complaint's files didn't find any other complaints associated to lot number involved on this event.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 physician attempted to close an arterial puncture with a celt acd vascular closure device of unknown size.When the physician attempted to eject the implant, it was noted that the ejection function did not work properly, and the implant remained connected to the device (and thus still in the patient).The physician decided to pull the implant out while still connected to the delivery system as one unit.He then held manual compression to achieve haemostasis.There were no complications.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported patient injury or complications.A search of the complaint files did not find any other complaints associated to the device lot number involved in this event.The device was returned for examination.The examination showed the 6f device was not used as per the ifu as it was returned with a 7f sheath attached.The examination also identified an internal broken plastic component.As the device was used off-label, the exact cause of the broken part could not be conclusively determined.No corrective or preventative actions are required at this time.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 final report being submitted by vasorum ltd.Investigation conclusions code 4247 was selected as there's no appropriate code for "off-label use".
Event or Problem Description
It was reported that physician attempted to close an arterial puncture with a celt acd vascular closure device of unknown size.When the physician attempted to eject the implant, it was noted that the ejection function did not work properly, and the implant remained connected to the device (and thus still in the patient).The physician decided to pull the implant out while still connected to the delivery system as one unit.He then held manual compression to achieve haemostasis.There were no complications.

• Brand Name: CELT ACD VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD.; 2012 orchard avenue; citywest business campus; dublin, D24WP W6; EI D24WPW6
• Manufacturer (Section G): VASORUM LTD.; 2012 orchard avenue; citywest business campus; dublin, D24WP W6; EI D24WPW6
• Manufacturer Contact: 2012 orchard avenue; citywest business campus; dublin, D24WP-W6
• MDR Report Key: 19124160
• Report Number: 3009984513-2024-00005
• Device Sequence Number: 18082573
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)260824(10)942883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/02/2024

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 Expiration Date: 08/24/2026
• Device Model Number: KCLT-06
• Device Lot Number: 942883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: Required Intervention
• Patient Sex: Unknown