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

Model Number 83775

Device Problems Entrapment of Device (1212); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

It was reported that the coil protruded upon removal.The target lesion was located in the moderately tortuous lumbar artery.A 4mm x 12cm idc was selected for use.During procedure, the coil prematurely detached inside the distal part of the microcatheter and was protruding from the catheter's tip upon removal.The procedure was completed with another of the same device.No 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11224243
• MDR Text Key: 228628583
• Report Number: 2134265-2021-00677
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729158752
• UDI-Public: 08714729158752
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0025690749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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