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

Model Number	10271
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery.A 12 x 3.50 rebel stent was advanced to treat the target lesion.However, while attempting to place the stent, the stent was kinked and could not be deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient was not harmed.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a rebel bms device.Visual inspection confirmed numerous kinks throughout the catheter.Functional testing was completed by using a water filled inflation device and connecting it to the hub.As pressure was applied the stent and balloon expanded.The reported deployment issue was not confirmed.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery.A 12 x 3.50 rebel stent was advanced to treat the target lesion.However, while attempting to place the stent, the stent was kinked and could not be deployed.The procedure was completed with another of the same device.No patient complications were reported and the patient was not harmed.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9554829
• Report Number: 2134265-2019-16386
• Device Sequence Number: 16892428
• Product Code: MAF
• UDI-Device Identifier: 08714729843726
• UDI-Public: 08714729843726
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/21/2020

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: 02/04/2022
• Device Model Number: 10271
• Device Catalogue Number: 10271
• Device Lot Number: 0023295322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR