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

Model Number	KCLT-06
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
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 the associated lot number.The device was not 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 final report being submitted by vasorum.Investigations findings code 4247 was used as no other feasible code was found for the preferred term "inconclusive".
Event or Problem Description
It was reported that the physician attempted to close a 6f puncture site with a 6f celt implant.It is not known whether the steps for deployment were correctly followed.Upon release of the implant from the delivery system, immediate bleeding was noted and manual pressure was applied to achieve hemostasis.The physician used an x-ray fluoroscopy and discovered that the implant was not at the arteriotomy site; it was now below the knee joint.The physician noted that there were no clinical signs of ischemia but he still elected to re-access the groin on the other side and performed an angiogram while the patient was still draped to determine if there was any evidence of reduced blood flow in the artery below the implant.This angiogram revealed that the celt implant was in the proximal peroneal artery but there was no evidence of reduced flow.The patient was then brought to recovery with no complications.The patient remained in the hospital for hydration and planned removal of the device by snaring.The implant was successfully retrieved and removed a few days later.No complications were reported, and the patient was discharged without incident.

• 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: 16442135
• Report Number: 3009984513-2023-00001
• Device Sequence Number: 5835545
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)250803(10)916486
• 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: 2023
• Device Explanted 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): 02/27/2023

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: 08/03/2025
• Device Model Number: KCLT-06
• Device Lot Number: 916486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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