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

Model Number	KCLT-06
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
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 complaint files did not find any other complaints associated to the device lot number involved in this event.The device was not returned for examination.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 ltd.
Event or Problem Description
It was reported that the physician attempted to use a 6f celt acd to close a 6f arterial puncture.Upon ejection, it was noted that there was significant bleeding at the puncture site so manual compression was used to achieve hemostasis.Fluoroscopy showed the device embolized in the profunda.The patient had a scheduled surgery after the procedure (pre-scheduled, not related to the embolized implant) which proceeded as planned.Patient showed no signs of leg ischemia and the implant was left in the profunda without incident.Patient was discharged according to plan.
Event or Problem Description
It was reported that the physician attempted to use a 6f celt acd to close a 6f arterial puncture.Upon ejection, it was noted that there was significant bleeding at the puncture site so manual compression was used to achieve hemostasis.Fluoroscopy showed the device embolized in the profunda.The patient had a scheduled surgery after the procedure (pre-scheduled, not related to the embolized implant) which proceeded as planned.Patient showed no signs of leg ischemia and the implant was left in the profunda without incident.Patient was discharged according to plan.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.A search of the complaint files did not find any other complaints associated to the device lot number involved in this event.The device was not returned for examination.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 ltd.Following receipt of fda medsun report (b)(4) on the (b)(6) 2024, section h10 was updated with the medsun report reference as requested.No further action is required as an mdr was already submitted.

• 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: 19382089
• Report Number: 3009984513-2024-00006
• Device Sequence Number: 19775462
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)270124(10)943065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Model Number: KCLT-06
• Device Lot Number: 943065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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