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

Model Number	KCLT-05
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that physician attempted to use a 5f celt to close a 5f arterial access puncture.The physican noted that when he attempted to deploy the distal wing, the handle did not fully pop back.An ultrasound was performed which revealed that the distal wings did not fully open.The sheath and the delivery system with the implant attached were removed from the patient and manual compression was applied to achieve hemostasis.The patient had no complications and was discharged the same day.No implant remained in the patient.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.A search of the complaints files didn't find any other complaint with the associated lot number.The device with the implant attached has been returned for detailed analysis.This report is the initial report being submitted by vasorum.A follow up report will be submitted as soon as further information on this event becomes available.
Event or Problem Description
It was reported that physician attempted to use a 5f celt to close a 5f arterial access puncture.The physican noted that when he attempted to deploy the distal wing, the handle did not fully pop back.An ultrasound was performed which revealed that the distal wings did not fully open.The sheath and the delivery system with the implant attached were removed from the patient and manual compression was applied to achieve hemostasis.The patient had no complications and was discharged the same day.No implant remained in the patient.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.A search of the complaints files didn't find any other complaint with the associated lot number.The device with the implant attached has been was returned for detailed analysis.A damaged component was identified.This may have led to the failure of the implant to deploy.However, a definitive conclusion as to the cause of the damage to the component was not identified.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.

• 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, D24W9 W6; EI D24W9W6
• Manufacturer Contact: 2012 orchard avenue; citywest business campus; dublin, D24W9-W6
• MDR Report Key: 15930981
• Report Number: 3009984513-2022-00013
• Device Sequence Number: 4347419
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)250830(10)919603
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2025
• Device Model Number: KCLT-05
• Device Lot Number: 919603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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