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

Model Number	KCLT-07
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
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 associated lot number.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 unless otherwise requested by the fda.
Event or Problem Description
It was reported that while attempting to deploy the proximal wing the physician noticed that the device felt as if it pulled through the arterial wall.It appears that physician ejected the implant from the delivery system at this point as the implant is reported to be in the soft tissue under the skin.The procedure was completed and manual pressure held for 10 minutes.3 days later the patient was brought back to the facility with symptoms of pseudoaneurysm.The physician used a thrombin injection to treat the pseudoaneurysm.There was no further incident and to our knowledge the patient is now well.On a further update implant was observed to be away from the arterial wall in the tissue tract.

• 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: 17681064
• Report Number: 3009984513-2023-00007
• Device Sequence Number: 6281469
• Product Code: MGB
• UDI-Device Identifier: 05391530280129
• UDI-Public: (01)05391530280129(17)250301(10)904795
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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: 01/23/2025
• Device Model Number: KCLT-07
• Device Lot Number: 904795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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