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

Model Number	KCLT-05
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that physician attempted to close a 5f sheath with the 5f celt device.Upon ejection of the implant bleeding was noted and manual compression was applied.The physician chose to immediately xray and discovered the implant was in the superficial femoral artery.Pulses were checked and they were good.The patient showed no signs of ischemia and was discharged the same day with no issues.
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 found one other report with the involved lot number (2021-00021).The investigation was based on the user facility information and testing & evaluation of actual device.This report is the final report being submitted by vasorum unless otherwise requested by the fda.All available information has been placed on file in the customer complaint files of vasorum ltd for appropriate tracking, trending and follow-up.

• 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: 12999164
• Report Number: 3009984513-2021-00024
• Device Sequence Number: 20152314
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)240906(10)900118
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/14/2021

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: 09/06/2024
• Device Model Number: KCLT-05
• Device Lot Number: 900118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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: Male