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

Model Number	KCLT-6F
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2018
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.After step 3, physician noted immediate signs of a failed deployment (bleeding).Manual compression was used to gain hemostasis.Physician used fluoroscopy to locate the implant which appeared to be somewhere in the sfa.The physician gained new 6f antegrade access.Upon fluoroscopy it was noted that the device appeared to be in the trifurcation, specifically in the origin of the anterior tibial artery which was chronically occluded below the implant (not due to the device).The physician then attempted to snare the device and was subsequently successful in doing so.An attempt was made to then remove the device and sheath together after wedging the implant into the distal end of the sheath.When the sheath was removed, the device appeared to be stuck at the arteriotomy.After some attempts to pull it out, the physician felt it made sense clinically to send the patient to a local hospital for a surgical cutdown to remove the snared device.
Event or Problem Description
Device was deployed.After step 3, physician noted immediate signs of a failed deployment (bleeding).Manual compression was used to gain hemostasis.Physician used fluoroscopy to locate the implant which appeared to be somewhere in the sfa.The physician gained new 6f antegrade access.Upon fluoroscopy it was noted that the device appeared to be in the trifurcation, specifically in the origin of the anterior tibial artery which was chronically occluded below the implant (not due to the device).The physician then attempted to snare the device and was subsequently successful in doing so.An attempt was made to then remove the device and sheath together after wedging the implant into the distal end of the sheath.When the sheath was removed, the device appeared to be stuck at the arteriotomy.After some attempts to pull it out, the physician felt it made sense clinically to send the patient to a local hospital for a surgical cutdown to remove the snared device.
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) 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.(b)(4).

• 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: 7956250
• Report Number: 3009984513-2018-00001
• Device Sequence Number: 1386621
• Product Code: MGB
• UDI-Device Identifier: 05391530280082
• UDI-Public: (01)05391530280082(17)210430(10)635129
• 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: 635129
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/11/2018
• Device Age: 5 MO
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/11/2018
• 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: 87 YR