MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 38265

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2020

Event Type  malfunction  

Event Description

It was reported that tip detachment occurred.An imager ii angiographic catheter was selected for a left ventriculography procedure.The imager catheter was loaded onto a.035 x 150 guidewire and prior to insertion into the patient, the tip of the imager catheter detached.The procedure was completed with another of the same device.There were no patient complications.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11003780
• MDR Text Key: 221541969
• Report Number: 2134265-2020-17643
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355885
• UDI-Public: 08714729355885
• Combination Product (y/n): N
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Model Number: 38265
• Device Catalogue Number: 38265
• Device Lot Number: 0000137926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1