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

Model Number	10275
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 28 x 4.00 rebel bms stent was selected for use.However, during preparation, it was noticed that the stent struts were broken.The procedure was completed with another of the same device and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a rebel bms balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.The balloon was tightly folded, and the stent was crimped.There was stent damage 13mm proximal of the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that stent damage occurred.A 28 x 4.00 rebel bms stent was selected for use.However, during preparation, it was noticed that the stent struts were broken.The procedure was completed with another of the same device and no patient complications were 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: 9935907
• Report Number: 2134265-2020-04675
• Device Sequence Number: 755359
• Product Code: MAF
• UDI-Device Identifier: 08714729844013
• UDI-Public: 08714729844013
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 05/05/2020

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: 10/01/2021
• Device Model Number: 10275
• Device Catalogue Number: 10275
• Device Lot Number: 0022733889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/03/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1