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

Model Number	10272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 16 x 4.00 rebel stent was selected for use.However, during unpacking, it was noted that the shaft was broken in half.
Event or Problem Description
It was reported that shaft break occurred.A 16 x 4.00 rebel stent was selected for use.However, during unpacking, it was noted that the shaft was broken in half.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a rebel bms balloon catheter, product mandrel, and balloon protector.The device was microscopically and visually examined.There was separation of the device at 118.4cm from the strain relief at the exit notch.A 16mm distally from the separation, was a buckled guidewire lumen 3mm in length with the product mandrel visible in the buckle.Within the buckle there was a hole punctured in the guidewire lumen.The distal portion of the separation presented 19mm of stretched down guidewire lumen.There was an additional buckle in the guidewire lumen proximal to the balloon for a length of 1mm.The balloon was tightly folded, and the stent presented no damage or irregularities and was still intact and in place.The balloon protector was also over the balloon at the point the device was returned.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12182249
• Report Number: 2134265-2021-09155
• Device Sequence Number: 13684157
• Product Code: MAF
• UDI-Device Identifier: 08714729843801
• UDI-Public: 08714729843801
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 04/14/2022
• Device Model Number: 10272
• Device Catalogue Number: 10272
• Device Lot Number: 0023643497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1