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

Model Number	38270
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11831284
• Report Number: 2134265-2021-05963
• Device Sequence Number: 4367802
• Product Code: DQO
• UDI-Device Identifier: 08714729354925
• UDI-Public: 08714729354925
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1