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

Model Number	10273
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent damage occurred.A 20 x 2.50 rebel stent was selected for use.However, when the device was taken out from the package, the stent was damaged.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that stent damage occurred.A 20 x 2.50 rebel stent was selected for use.However, when the device was taken out from the package, the stent was damaged.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.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 was blood in the inflation lumen.The balloon was tightly folded.The inner shaft was buckled 79mm from the tip.There was a hole in the buckled area.The damage was consistent with an interaction from a guidewire.The stent was damaged.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11123705
• Report Number: 2134265-2020-18449
• Device Sequence Number: 17078785
• Product Code: MAF
• UDI-Device Identifier: 08714729843832
• UDI-Public: 08714729843832
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 04/20/2023
• Device Model Number: 10273
• Device Catalogue Number: 10273
• Device Lot Number: 0025453352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1