MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2D HELICAL - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	82885
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter tip during removal.The target lesion was located in the left renal artery.A 9 mm x 60 mm 2d helical - 35 coil was selected for use in a left renal artery embolization.During the procedure, the coil was stuck half in and half out of the very end.Intermittent flush was used.The catheter was removed with the coil inside and replaced.The procedure was completed with another of the same coil device to successfully embolize the vessel.No patient complications reported and patient was good post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for evaluation.A visual and microscopic examination revealed that the main coil returned outside the non-bsc catheter and was found stretched.The proximal and distal main coil have a smooth surface.No more damages were found in the device.A dimensional inspection revealed that the main coil was within its specification.
Event or Problem Description
It was reported that the coil protruded from the catheter tip during removal.The target lesion was located in the left renal artery.A 9 mm x 60 mm 2d helical - 35 coil was selected for use in a left renal artery embolization.During the procedure, the coil was stuck half in and half out of the very end.Intermittent flush was used.The catheter was removed with the coil inside and replaced.The procedure was completed with another of the same coil device to successfully embolize the vessel.No patient complications reported and patient was good post procedure.

• Brand Name: 2D HELICAL - 35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9763814
• Report Number: 2134265-2020-02027
• Device Sequence Number: 10888707
• Product Code: KRD
• UDI-Device Identifier: 08714729158868
• UDI-Public: 08714729158868
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0021568372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: 5 FR ANGIODYNAMICS C2; CATHETER: 5 FR ANGIODYNAMICS C2; CATHETER: 5 FR ANGIODYNAMICS C2