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

Model Number	KCLT-05
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/09/2022
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 record files found one other event (b)(4) with the same lot number however, there is no evidence to suggest that the 2 events are related.This report is the final report being submitted by vasorum.All available information has been placed on file in the customer complaint files of vasorum ltd for appropriate tracking, trending and follow-up.(b)(4).
Event or Problem Description
It was reported that a physician attempted to use a celt acd 5f to close a 5f arterial puncture.Steps were performed as per ifu but bleeding was noticed immediately upon ejection of the implant.Manual compression was performed to achieve hemostasis.The physician then elected to reaccess the arterial system from the opposite groin to determine if the implant had embolized and if so what location.The angiogram revealed the implant in the middle of the peroneal artery but was not occlusive and the patient had no symptoms.The patient was held for observation overnight and a vascular surgeon was consulted.It is not known if the patient developed any symptoms the following day but it is understood the surgeon elected to perform surgery to remove the implant.It is not known what surgery was performed specifically but it is understood that the peroneal artery was sacrificed during the surgery.The patient was reported to be stable and was discharged from the hospital.

• 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: 15993944
• Report Number: 3009984513-2022-00016
• Device Sequence Number: 6103199
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)250518(10)915476
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/16/2022

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: 05/18/2025
• Device Model Number: KCLT-05
• Device Lot Number: 915476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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