MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil protruded in the vessel and migrated to another vessel.A 3mm x 10cm idc 18 soft coil was selected for use.During the procedure, it was noted that the coil backed out from the artery after it was deployed fully in the vessel.The physician then attempted to snare the coil; however, it recoiled back out into another vessel and was not retrieved.The procedure was completed with another of the same device and a smaller sized coil.No further patient complications were reported and the patient's status was fine.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8417641
• Report Number: 2134265-2019-02377
• Device Sequence Number: 13933377
• Product Code: KRD
• UDI-Device Identifier: 08714729158721
• UDI-Public: 08714729158721
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2021
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 21915724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/13/2019
• 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