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

Model Number 29460

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2018

Event Type  malfunction  

Event Description

It was reported that tip fracture occurred.A 135/10 renegade hi-flo kit was selected for use.During preparation, it was noted that the guidewire could not be pulled out during flushing after unpacked; and, tip of the microcatheter was found fractured.The procedure was completed with another of the same device.No patient complications were reported and patient's status is stable.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8020421
• MDR Text Key: 125603971
• Report Number: 2134265-2018-62446
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0021562838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2018
• 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