MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 80617

Device Problems Collapse (1099); Obstruction of Flow (2423)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the form of shaft damage from approx.2 mm to 3.6 cm from the tip.An obstruction was determined to be approx.2 cm from the tip and was removed with a guide wire.Ftir testing showed the obstruction to be similar in composition to the fluorocarbon fiber used in the inner tube.Further analysis revealed damage in the form of kinks 131.5, 141 cm and 142 cm from the hub.Inspection of the remainder of the device revealed no damage or irregularities.

Event Description

Based on device analysis completed on 05apr2021.It was reported that distal part of the catheter was bulging.A 150/30 renegade stc 18 was selected for use.Upon preparation, it was noted that the distal part of the microcatheter was obstructed.Subsequently, there was a bulging in the distal part approximately 3-4cm.No patent complications were reported.However, device analysis revealed an obstruction of foreign material.

• Brand Name: RENEGADE STC 18
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11744885
• MDR Text Key: 248035911
• Report Number: 2134265-2021-05234
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444510
• UDI-Public: 08714729444510
• Combination Product (y/n): N
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0023281281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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