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

Model Number	10275
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 28 x 4.00 rebel bms stent was advanced for treatment.However, while advancing it over the wire, the shaft break.The device was pulled out and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 28 x 4.00 rebel bms stent was advanced for treatment.However, while advancing it over the wire, the shaft break.The device was pulled out and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a rebel bms balloon catheter.The device was visually and microscopically examined.At 83.4cm from the strain relief there was a hypotube separation.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There were numerous hypotube kinks, and contrast was present in the inflation lumen and the balloon.The balloon was tightly folded, and the stent was found to be intact and in place.Product analysis confirmed the reported break as there was separation of the device.There were also numerous unreported kinks.
Event or Problem Description
It was reported that shaft break occurred.A 28 x 4.00 rebel bms stent was advanced for treatment.However, while advancing it over the wire, the shaft break.The device was pulled out and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13538708
• Report Number: 2134265-2022-01553
• Device Sequence Number: 17474000
• Product Code: MAF
• UDI-Device Identifier: 08714729844013
• UDI-Public: 08714729844013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P130030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 11/16/2023
• Device Model Number: 10275
• Device Catalogue Number: 10275
• Device Lot Number: 0026366291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown