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

Model Number	83775
Medical Device Problem Codes	Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device flowed to the periphery, embolized and was removed by snare.The target lesion area was located in the severely tortuous renal artery.A 5mm x 12cm idc was selected for use.During the procedure, it was noted that the device was deployed fully.However, the coil could not be crimped well to the vessel and flowed to the periphery.Subsequently, it embolized in the distal part of the lesion and was removed using a gooseneck snare.The procedure was completed with another of the same device.No further patient complications reported.

• 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: 12408030
• Report Number: 2134265-2021-11013
• Device Sequence Number: 11857682
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 09/06/2023
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0026138480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: MICROCATHETER-BREAKTHROUGH 2 MARKER
• Outcome Attributed to Adverse Event: Required Intervention