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

Model Number 83775

Device Problems Premature Activation (1484); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  Injury  

Event Description

It was reported that the coil was not placed within the target lesion.A 4mmx12cm idc embolic coil was selected for use in a chemo embolization of the liver procedure.The 4mmx12cm idc embolic coil was advanced through the renegade catheter and deployed prematurely not within the intended target location of the liver.The procedure was completed with a different device.No further patient complications were reported.

• Brand Name: IDC
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11554622
• MDR Text Key: 241782747
• Report Number: 2134265-2021-03497
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729158752
• UDI-Public: 08714729158752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2022
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0023694915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other