MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 29417

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device showed multiple kinks and bends.The device also showed stretching and separations located 24.5 and 26.5cm from the hub.The device was not completely separated the inner liner was still attached.The device could not be functionally tested in a guiding catheter due to the damage on the device.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

Reportable based on device analysis completed on 07may2020.It was reported that the device could not cross lesion.The 50% stenosed target lesion was in an acute angled and moderately calcified renal artery.A 105/3.0/2.5/.021/20 renegade was selected for use.During procedure, it was noted that the device could not cross the lesion due to the gap between guidewire and microcatheter.The procedure was completed with a different device.There were no patient complications reported.However, device analysis revealed device separation.

• Brand Name: RENEGADE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 10088082
• MDR Text Key: 192028441
• Report Number: 2134265-2020-06899
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729375395
• UDI-Public: 08714729375395
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2020

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: 10/01/2021
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0022877635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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
• Patient Age: 55 YR