MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY

Model Number	10276
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient's age is approximately (b)(6).Date of event: used the first day of the aware date as the event date not provided.
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified peroneal trunk.A 32 x 3.00mm rebel stent was advanced for treatment.However, while attempting to cross the area of stenosis, the stent delivery system broke in the middle about half way from the shaft.Since the shaft fractured outside of the body and the patient's sheath, the device was then removed and the procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient was fine.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10013588
• Report Number: 2134265-2020-05024
• Device Sequence Number: 11589057
• Product Code: MAF
• UDI-Device Identifier: 08714729844068
• UDI-Public: 08714729844068
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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: 11/03/2022
• Device Model Number: 10276
• Device Catalogue Number: 10276
• Device Lot Number: 0024705292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1