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

Model Number 29420

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a renegade hi-flo micro-catheter with the fathom guidewire returned stuck in the device.The hub, shaft and tip were microscopically examined.The renegade device showed multiple kinks, bends and stretching located throughout the length of the catheter shaft.It was noticed that the shaft showed a fracture approximately 28.5cm from the hub.The shaft was not completely separated the inner liner was still connected.The guidewire could not be removed due to the damage on the device.The device and the imager were hydrated and the renegade was attempted to be inserted into a 5fr imager angiographic catheter.The renegade would not transcend through the imager due to the damage that was on the renegade device.The inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 08 jan 2019.It was reported that crossing difficulties were encountered.A 135/20 renegade hi-flo micro-catheter was advanced for a liver cancer procedure but failed to cross to an 5f imaging catheter.The procedure was completed with a different device.No patient serious injury or adverse event were reported.The patient was stable post procedure.However, returned device analysis revealed shaft fractured.

• 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; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8267369
• MDR Text Key: 133743486
• Report Number: 2134265-2019-00207
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0021438882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• 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: 67 YR
• Patient Weight: 58