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

Model Number	KCLT-05
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A celt 5f device was used to attempt to close a 5f arterial puncture.During the deployment of the proximal wing it was noted that after several turns the proximal wing did not appear to open.The physician then attempted to advance to last step of ejecting the implant.He was unable to eject the implant, so he elected to instead abort by pulling out the entire delivery system (including the implant still attached) and used manual compression to achieve hemostasis.The patient was discharged the same day with no complications.

• 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
• MDR Report Key: 13063861
• Report Number: 3013768822-2021-00014
• Device Sequence Number: 4152850
• Product Code: MGB
• UDI-Device Identifier: 05391530280006
• UDI-Public: (01)05391530280006(17)240906(10)90018
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2021
• Report Date (Section F): 11/24/2021

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 Expiration Date: 09/06/2024
• Device Model Number: KCLT-05
• Device Lot Number: 900118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/26/2021
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/24/2021