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

Model Number	KCLT-6F
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the process of this complaint, attempts were made to obtain complete event, patient and device information.
Event or Problem Description
Device was deployed according to the proper steps, but wasn't pulled all the way to the arteriotomy before turning step 2.It was then released in the vessel.Doctor re-accessed in the same location and placed a 6 x/ 40mm zilver stent to capture the device against the wall of the sfa.
Additional Manufacturer Narrative
During the process of this complaint, attempts were made to obtain complete event, patient and device information.Vasorum ltd is submitting this report on the behalf of (b)(4), 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.(b)(4).
Event or Problem Description
Device was deployed according to the proper steps, but wasn't pulled all the way to the arteriotomy before turning step 2.It was then released in the vessel.Doctor re-accessed in the same location and placed a 6 x/ 40mm zilver stent to capture the device against the wall of the sfa.

• 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, leinster D24 W PW6; EI D24 WPW6
• MDR Report Key: 8004263
• Report Number: 3009984513-2018-00002
• Device Sequence Number: 19179198
• Product Code: MGB
• UDI-Device Identifier: 05391530280082
• UDI-Public: (01)05391530280082(17)210628(10)654934
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 06/28/2021
• Device Model Number: KCLT-6F
• Device Lot Number: 654934
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/05/2018
• Device Age: 3 MO
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 04/04/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 84