MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH

Model Number 29420

Device Problems Entrapment of Device (1212); Stretched (1601); Difficult to Advance (2920)

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: RENEGADE HI-FLO
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 11823708
• MDR Text Key: 250633069
• Report Number: 2134265-2021-05964
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: 08714729280637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0024753622
• 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: 11/12/2019
• 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