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

Model Number	KCLT-06
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on attempting to use the celt acd device to close a 6f arterial puncture, the customer thought that the distal wing was open but when attempting to withdraw to the arteriotomy the device slipped out of the patient.It was noted that the distal wings did not open.Manual compression was used to achieve hemostasis and the patient was discharged on time without incident.No device was left 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 was not possible as lot number was not provided.The device is being returned to vasorum ltd returned for analysis.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.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned to vasorum ltd for analysis.No issues with the device were identified.A search of the complaint's files found one other report (mdr 3009984513-2021-00013) with the involved lot number.There was no evidence to suggest the two events were related.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 on attempting to use the celt acd device to close a 6f arterial puncture, the customer thought that the distal wing was open but when attempting to withdraw to the arteriotomy the device slipped out of the patient.It was noted that the distal wings did not open.Manual compression was used to achieve hemostasis and the patient was discharged on time without incident.No device was left in the patient.

• 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: 16617856
• Report Number: 3009984513-2023-00002
• Device Sequence Number: 6164813
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)230912(10)883954
• 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): 04/14/2023

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: 12/09/2023
• Device Model Number: KCLT-06
• Device Lot Number: 883954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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