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

Model Number	KCLT-06
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 identified one other report (for a different type of event) with the lot number 943118 ((b)(6)).The device has been returned to vasorum ltd for examination.
Event or Problem Description
It was reported that a 6f celt device was attempted to use following a diagnostic angiography.It would not introduce correctly, meeting resistance upon introduction to the 6f sheath and subsequently shredded the sheath as it was removed.An attempt was then made to then use a mynx device to close the puncture, but that also failed to insert.The groin puncture was ultimately managed with manual compression.
Event or Problem Description
It was reported that a 6f celt device was attempted to use following a diagnostic angiography.It would not introduce correctly, meeting resistance upon introduction to the 6f sheath and subsequently shredded the sheath as it was removed.An attempt was then made to then use a mynx device to close the puncture, but that also failed to insert.The groin puncture was ultimately 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 procedure was completed with manual compression.A search of the complaint's files identified one other report (for a different type of event) with the lot number: 943118 (cc-15-2024).The device was returned to vasorum ltd for examination.After completing the dimensional inspection, the device was tested and successfully deployed, demonstrating full functionality, including proper ejection of the implant.The device met all operational and performance criteria.Detailed examination under magnification, as shown in figure 3, confirmed that the implant exhibited no sharp edges, burrs, anomalies, deformations, or oversized characteristics that could account for the reported issues, such as resistance during introduction or sheath shredding.Unless the device was improperly handled or not used in accordance with the instructions for use (ifu), the described complications could not be attributed to the device itself.The returned terumo pinnacle sheath displayed significant damage i.E.Kinking near the proximal end of the sheath.Following detailed examination of the sheath, the most probable root cause of the observed damage to the terumo pinnacle introducer sheath was the application of excessive force during the introduction of the 6f celt acd device into the sheath that may have been bent, kinked, or otherwise compromised prior to or during the procedure.When the sheath is deformed or over bent, the device can bind against the lower edge of the sheath, creating resistance.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.

• 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: 21137432
• Report Number: 3009984513-2025-00001
• Device Sequence Number: 6825384
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)271125(10)943188
• 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 Model Number: KCLT-06
• Device Lot Number: 943118
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• 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: 12/02/2024
• 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