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

Model Number	KCLT-06
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1- during the processing of this complaint all attempts were made to obtain complete event, patient and device information.2- this report is the final report being submitted by vasorum unless otherwise requested by the fda.3- vasorum ltd is submitting this report on behalf of dj medical consulting & distribution llc, in accordance with the conditions outlined with the mdr exemption e2017048.Vasorum ltd trinitas house 2012 orchard avenue citywest business park d24 wpw6 dublin - ireland dj medical consulting and distribution llc 20 ryans lane duxbury ma 02332 usa.
Event or Problem Description
According to the doctor, he turned the handle clockwise, it made the 'click', everything seemed normal but the set of wings didn't open.When pulling back the instrument, there was no resistance and the tube slipped out and the patient suffered a big blood loss.As there was no resistance due to not opening of the inner 'star' by pulling everything against the arterial wall, celt device and introducer sheath came out of the patient and then closed by manual compression.The implant was deployed after the device was pulled out of patient.It was a cardiac procedure.

• Brand Name: CELT ACD VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): VASORUM LTD; 2012 orchard avenue; citywest business park; dublin, D24 W PW6; EI D24 WPW6
• MDR Report Key: 8690643
• Report Number: 3009984513-2019-00002
• Device Sequence Number: 11246700
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)200930(10)492153
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: 09/30/2020
• Device Model Number: KCLT-06
• Device Lot Number: 492153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Distributor Facility Aware Date: 06/14/2018
• Device Age: 8 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 06/12/2019
• 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