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

Model Number	29460
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter fracture occurred.The target lesion was located in the liver artery.A 135/10 renegade hi-flo kit was selected for use.The device was unpacked and the guidewire and protector were removed.Then the device was flushed through the flushing passages on both sides of the protector and the microcatheter was removed.However, the device was found deformed and fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter in the shipping hoop.The device was removed from the shipping tube.The hub, shaft and tip were microscopically examined.This device showed damage consisting of 1 fracture on the shaft located at 6.5cm from the hub.The shaft was not completely separated the inner liner was still connected.The stretching and the fracture that was noticed on the device are consistent with the device being removed from the shipping tube without being completely hydrated with saline.The device showed kink damage located approximately 6cm from the hub.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
It was reported that a catheter fracture occurred.The target lesion was located in the liver artery.A 135/10 renegade hi-flo kit was selected for use.The device was unpacked and the guidewire and protector were removed.Then the device was flushed through the flushing passages on both sides of the protector and the microcatheter was removed.However, the device was found deformed and fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8138520
• Report Number: 2134265-2018-63658
• Device Sequence Number: 2154926
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• 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,Followup
• Report Date (Section B): 01/04/2019

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: 10/30/2019
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0021447895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 46