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

Model Number 29460

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 07/13/2021

Event Type  malfunction  

Event Description

It was reported that the microcatheter fractured.A renegade hi flo infusion catheter was selected for use in the main hepatic artery.The renegade catheter was used along with a 0.018 transcend guidewire.During the advancement of the renegade catheter into the distal hepatic artery, despite multiple attempts, the catheter could not be advanced to the intended location.The physician withdrew the catheter and found that the renegade infusion catheter fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post-procedure.

Event Description

It was reported that the microcatheter fractured.A renegade hi flo infusion catheter was selected for use in the main hepatic artery.The renegade catheter was used along with a 0.018 transcend guidewire.During the advancement of the renegade catheter into the distal hepatic artery, despite multiple attempts, the catheter could not be advanced to the intended location.The physician withdrew the catheter and found that the renegade infusion catheter fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post-procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the renegade showed damage in the form of a fracture located 23cm from the hub.The device was not completely separated the inner liner was still intact.There was severe stretching located 55.5cm to 66.5cm from the hub.No other damage was noticed.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: RENEGADE HI-FLO KIT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12286687
• MDR Text Key: 265354304
• Report Number: 2134265-2021-09891
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• Combination Product (y/n): N
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0026193474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60