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

Model Number	83775
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(4).
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.The target lesion was located in the severely tortuous liver artery.A 5mmx12cm idc-18 coil was selected for use.During the procedure, it was noted that the coil became stuck in the distal part of the microcatheter.Furthermore, when the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the microcatheter.The coil was pulled out from the patient's body and the procedure was completed with another of the same device.No complications were reported and there was no patient injury.

• 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: 11012407
• Report Number: 2134265-2020-17813
• Device Sequence Number: 3617936
• Product Code: KRD
• UDI-Device Identifier: 08714729158776
• UDI-Public: 08714729158776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 12/07/2021
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0023145572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1