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

Model Number	10272
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 16 x 3.00 rebel bms stent was selected for use.However, it was noted that the stent was damaged upon opening the package.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 79mm from the tip, the guidewire lumen was buckled and prolapsed for a length of 1mm.The balloon was tightly folded.The stent was dislodged and moved distally over the balloon by approximately 3mm.The strut rows 6-9 (counting from proximal end to distal end) were pulled and balled up.There were no further damages to the device, and no fluids were found within the device.There was no indication the device was inflated or an attempt to deploy the stent was made.Photo media reviewed was found to be not applicable as it depicted box packaging with damage similar to handling as there were creases on the edges of the box indicating the box was opened given the device was reportedly removed from packaging.
Event or Problem Description
It was reported that stent damage occurred.A 16 x 3.00 rebel bms stent was selected for use.However, it was noted that the stent was damaged upon opening the package.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: 14086338
• Report Number: 2134265-2022-04232
• Device Sequence Number: 13983812
• Product Code: MAF
• UDI-Device Identifier: 08714729843788
• UDI-Public: 08714729843788
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 11/02/2023
• Device Model Number: 10272
• Device Catalogue Number: 10272
• Device Lot Number: 0026284522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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