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

Model Number	80617
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was fractured.A renegade stc-18 microcatheter was selected for use.During the procedure, introducing the microcatheter was smooth.However, when the chemo-drug was injected, the physician found that the flow of the drug was abnormal and did not go toward the target vessel under angiogram.So, he removed the microcatheter without friction and tested it outside of the patient's body.Then, he found a fracture in the distal of the microcatheter.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10514737
• Report Number: 2134265-2020-12506
• Device Sequence Number: 3539294
• Product Code: DQO
• UDI-Device Identifier: 08714729444404
• UDI-Public: 08714729444404
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K023681
• 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): 09/10/2020

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: 06/18/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0024133107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1