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

Model Number 38270

Device Problem Entrapment of Device (1212)

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

Event Date 04/23/2021

Event Type  malfunction  

Event Description

It was reported that the renegade was stuck and could not be removed from the imager.A 135/10 renegade hi-flo and a imager ii angiographic catheter were selected for use as ancilliary devices for a preclinical study for liquid embolic prototypes.During procedure, renegade microcatheter was placed through a imager ll angiographic catheter.Once passed out the tip of the imager, the renegade was unable to be advanced to the location.The renegade appeared to be locked within the imager ll angiographic catheter and was unable to be advanced to the treatment site.The renegade was pulled pretty firm trying to get it back into the imager catheter and it became stretched.The device was aggressively pulled out in trying to separate the two devices and this occurred both inside and outside the body.However, the renegade could not be removed from the imager and renegade had to be cut.The procedure was completed with a new imager ll and renegade catheter.

• 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: 11831284
• MDR Text Key: 250862626
• Report Number: 2134265-2021-05963
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729354925
• UDI-Public: 08714729354925
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000097254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2014
• 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