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

Model Number	29420
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8267369
• Report Number: 2134265-2019-00207
• Device Sequence Number: 13900318
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 58