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

Model Number	10275
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A percutaneous coronary intervention was being performed.A 28 x 4.00 rebel stent was advanced for treatment.However, during procedure, it was noted that the stent was crumpled up and there was damage on the struts.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9454215
• Report Number: 2134265-2019-15585
• Device Sequence Number: 16666720
• Product Code: MAF
• UDI-Device Identifier: 08714729844013
• UDI-Public: 08714729844013
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/11/2019

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 Model Number: 10275
• Device Catalogue Number: 10275
• Device Lot Number: 0023621789
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1