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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following is as reported in mw5148762: new arterial closure device used post procedure to close right femoral arteriotomy.It appears all deployment steps were followed correctly but device did not fully deploy.Due to incomplete deployment, device migrated down right leg arterial system.Device is non-occlusive.No clinical signs, symptoms or conditions.
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 same lot number.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.Investigation findings code 4247 was used as no other feasible code was found for the preferred term "undeterminable".

• 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: 18532791
• Report Number: 3009984513-2024-00001
• Device Sequence Number: 6676094
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)260717(10)942844
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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-05
• Device Lot Number: 942844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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