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

Model Number	KCLT-05
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a physician attempted on multiple occasions to insert 5f celt devices into 5f cordis avanti sheaths.In each situation, the physician reported experiencing excessive resistance during insertion and was unable to advance the delivery system completely into the sheath.In each situation, a new 5f celt was used with a different lot number and the closure procedure was completed without incident.Devices are being returned to vasorum ltd for inspection.
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 with the same lot number associated with a previous mdr (2024-00010).Devices are being returned to vasorum ltd.For examination.A review of the lot records did not identify any non-conformances or issues during the production of this particular lot.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 by vasorum ltd.
Event or Problem Description
It was reported that a physician attempted on multiple occasions to insert 5f celt devices into 5f cordis avanti sheaths.In each situation, the physician reported experiencing excessive resistance during insertion and was unable to advance the delivery system completely into the sheath.In each situation, a new 5f celt was used with a different lot number and the closure procedure was completed without incident.Devices are being returned to vasorum ltd for inspection.
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 found 1 other report with the same lot number (2024-00010).Devices have been returned to vasorum ltd.For examination.Based on the limited information available for review and the testing and evaluation of the returned device, it is not possible to determine what factors may have contributed to the issue reported.Neither the device analysis, nor the information available for review suggest that the reported event could be related to the design or manufacturing process of the unit.No faults were identified during the test process.The 5f cordis avanti sheath demonstrated adequate performance for the 5f celt devices, with little to no resistance observed.A review of the lot records did not identify any non-conformances or issues during the production of this particular lot.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.Investigation findings code 4247 was used as no other feasible code was found for the preferred term "inconclusive".Investigation conclusions code 4316 was used as no other feasible code was found for the preferred term "inconclusive".

• 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: 19859552
• Report Number: 3009984513-2024-00011
• Device Sequence Number: 20713643
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)260913(10)942889
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/18/2024

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: 09/13/2026
• Device Model Number: KCLT-05
• Device Lot Number: 942889
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• 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