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

Model Number	KCLT-05
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.There were no reported health consequences or impact for the patient associated to this event.A search of the complaint's files did not identify any other report with the lot number 942914.The device has been returned to vasorum ltd for examination.
Event or Problem Description
It was reported that a 5f celt device was attempted to be advanced into a 5f cordis avanti sheath at the end of the procedure.It met resistance upon introduction to the 5f sheath and it would not advance to fully engage.The celt device was withdrawn and the groin was managed with manual compression.
Event or Problem Description
It was reported that a 5f celt device was attempted to be advanced into a 5f cordis avanti sheath at the end of the procedure.It met resistance upon introduction to the 5f sheath and it would not advance to fully engage.The celt device was withdrawn and the groin was managed with manual compression.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.There were no reported health consequences or impact for the patient associated to this event.The celt device was withdrawn and the groin managed with manual compression.A search of the complaint's files did not identify any other report with the lot number 942914.The device was returned to vasorum ltd for examination together with the procedural sheath used.An additional number of unused devices from unknown lot numbers were also provided.Following detailed examination of the used device it was confirmed to be within specification and met the design and manufacturing criteria.This device was successfully passed through a different cordis avanti sheath from a different batch.The additional 3 unused sterile devices from unknown lots numbers were also confirmed to be within specification.These also successfully passed through an additional supplied cordis avanti sheath though significant friction was encountered during the insertion process.The observed issue of sheath insertion resistance is attributed to a tolerance difference between the outer diameter (od) of the 5f celt acd device and the inner diameter (id) of the cordis avanti sheath.The inability to pass through a cordis introducer sheath is a compatibility issue caused by differences in tolerances between the device and the sheath, not a failure of the device itself.No corrective/preventative actions will be taken at this time.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 unless requested by the fda.A number of codes have been updated since the submission of the initial mdr report.Investigation findings code 4247 was used as no other feasible code was found for definition "insertion resistance of a device when used with another device".Investigation conclusions code 4316 was used as no other feasible code was found for definition "device not compatible with another device used in the procedure".

• 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: 21137398
• Report Number: 3009984513-2025-00002
• Device Sequence Number: 15161019
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)260927(10)942914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2026
• Device Model Number: KCLT-05
• Device Lot Number: 942914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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
• Patient Sex: Unknown