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

Model Number	KCLT-06
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/08/2024
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 report with the lot number (943118).The device is being returned to vasorum ltd.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 initial report being submitted.Health effect - clinical code 4581 was used as no other feasible code was found for the preferred term "bleeding".
Event or Problem Description
It was reported that physician deployed the 6f celt on a 6f sheath.Bleeding was noted upon ejection.Manual compression was applied.On fluoroscopy it was noted that the implant was embolized into the tp trunk.Despite the patient having adequate pulses, vascular surgery electively decided to retrieve the implant using an endovascular snare.The patient was admitted to the icu for high blood pressure (not related to the incident with the closure device) and was discharged with no groin complications.
Event or Problem Description
It was reported that physician deployed the 6f celt on a 6f sheath.Bleeding was noted upon ejection.Manual compression was applied.On fluoroscopy it was noted that the implant was embolized into the tp trunk.Despite the patient having adequate pulses, vascular surgery electively decided to retrieve the implant using an endovascular snare.The patient was admitted to the icu for high blood pressure (not related to the incident with the closure device) and was discharged with no groin complications.
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 files did not find any other report with the lot number (943118).The device was returned to vasorum ltd.For examination.There were no faults or defects identified with the celt 6f device or its components.All available information has been placed on file in the customer complaint files of vasorum ltd for appropriate tracking, trending and follow-up.No corrective/preventative actions will be taken at this time.This report is the final report being submitted by vasorum ltd unless requested by the fda.

• 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: 20829593
• Report Number: 3009984513-2024-00013
• Device Sequence Number: 19848272
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)270515(10)943118
• 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
• Device Implanted Year: 2024
• Device Explanted 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): 12/13/2024

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: 943118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2024
• Supplement Date Received by Manufacturer: 11/10/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 05/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 116 KG