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

Model Number	10271
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	11/16/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A 12 x 3.00 rebel stent was advanced for treatment but failed to cross.The patient went into cardiac arrest and died.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10971220
• Report Number: 2134265-2020-17065
• Device Sequence Number: 14526748
• Product Code: MAF
• UDI-Device Identifier: 08714729843719
• UDI-Public: 08714729843719
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: 10271
• Device Catalogue Number: 10271
• Device Lot Number: 0025703858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death