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

Model Number	KCLT-06
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 complaints didn't finid any other complaint with the same lot number.A review of the bhr/lot record was conducted with no relevant findings.A completion of reporting on the evaluation and testing of the returned device is pending.This report is the initial report being submitted by vasorum.All available information has been placed on file in the customer complaint files of vasorum ltd for appropriate tracking, trending and follow-up.
Event or Problem Description
It was reported that the user felt that the proximal wing of the implant did not seem to deploy as the handle on the delivery system kept rotating in a counter-clockwise manner.In view of this and the fact that bleeding was noticed to be coming up around the sheath, the user decided to dissect down to the device and found that the implant while still attached to the delivery was in the soft tissue.30 minutes of manual pressure was used to achieve hemostasis and the device with the implant attached was removed from the patient.The patient had no complications and was discharged on time.
Event or Problem Description
It was reported that the user felt that the proximal wing of the implant did not seem to deploy as the handle on the delivery system kept rotating in a counter-clockwise manner.In view of this and the fact that bleeding was noticed to be coming up around the sheath, the user decided to dissect down to the device and found that the implant while still attached to the delivery was in the soft tissue.30 minutes of manual pressure was used to achieve hemostasis and the device with the implant attached was removed from the patient.The patient had no complications and was discharged on time.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.A search of the complaints didn't finid any other complaint with the same lot number.A review of the bhr/lot record was conducted with no relevant findings.The actual device was returned for evaluation on 14-sep-2022 and analysis showed no defects with the device and it was working in accordance with specification.This report is the final report being submitted by vasorum.All available information has been placed on file in the customer complaint files of vasorum ltd for appropriate tracking, trending and follow-up.Medical device problem code 3191 was used as no other feasible code was found for the preferred term "adverse event without identified device problem".

• 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, D24W9 W6; EI D24W9W6
• Manufacturer Contact: 2012 orchard avenue; citywest business campus; dublin, D24W9-W6
• MDR Report Key: 15474607
• Report Number: 3009984513-2022-00009
• Device Sequence Number: 19914302
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)241114(10)900153
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 11/14/2024
• Device Model Number: KCLT-06
• Device Lot Number: 900153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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 Sex: Unknown