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

Model Number	29460
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was fractured.A 135/20 renegade hi-flo kit was selected for use.During unpacking, it was noted that the microcatheter was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a renegade microcatheter.The device was received in the shipping tube with approximately 6cm protruding out of the tube.Microscopic examination revealed that damage in the form of stretching and a kink located 5cm rom the hub.The device was not separated.The device was removed from the shipping tube and it was noticed that there was another stretched area and a kink located 19cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the microcatheter was fractured.A 135/20 renegade hi-flo kit was selected for use.During unpacking, it was noted that the microcatheter was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.

• 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: 9899286
• Report Number: 2134265-2020-03978
• Device Sequence Number: 2238360
• 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): 04/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0023510273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 55