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

Model Number	KCLT-6F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the processing of this complaint all attempts were made to obtain complete event, patient and device information.
Event or Problem Description
Device was deployed on (b)(6) 2018.Patient had no known symptoms post discharge.On (b)(6) 2018 the patient was brought in for an angiogram and the implant was discovered in the right sfa.The doctor attempted to snare the device via antegrade access.During this process the device was lost in the origin of the profunda on the contralateral leg.The doctor then performed contralateral access on the right leg, snared the device and dropped it intentionally in a branch of the internal iliac because this is a location where blood can easily perfuse around the implant and cause no clinical sequellae.
Additional Manufacturer Narrative
During the processing of this complaint all attempts were made to obtain complete event, patient and device information.Vasorum ltd is submitting this report on the behalf of dj medical consulting & distribution llc, in accordance with the conditions outlined with the mdr exemption e2017048.Vasorum ltd.(b)(4).Dj medical consulting and distribution llc.(b)(4).
Event or Problem Description
Device was deployed on (b)(6) 2018.Patient had no known symptoms post discharge.On (b)(6) 2018, the patient was brought in for an angiogram and the implant was discovered in the right sfa.The doctor attempted to snare the device via antegrade access.During this process the device was lost in the origin of the profunda on the contralateral leg.The doctor then performed contralateral access on the right leg, snared the device and dropped it intentionally in a branch of the internal iliac because this is a location where blood can easily perfuse around the implant and cause no clinical sequellae.

• 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 D24WP W6; EI D24WPW6
• MDR Report Key: 8128570
• Report Number: 3009984513-2018-00003
• Device Sequence Number: 16204187
• Product Code: MGB
• UDI-Device Identifier: 05391530280068
• UDI-Public: (01)05391530280068(17)210430(10)632628
• 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: 04/30/2021
• Device Model Number: KCLT-6F
• Device Lot Number: 632628
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/05/2018
• Device Age: 6 MO
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 57