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

Model Number	10274
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the heavily calcified posterior tibial artery.After a 45cm 5fr non-bsc sheath was placed and pre-dilatation was performed with 2mm and 2.5mm balloon catheters, a 24 x 2.50 rebel stent was selected for use.However, upon passing through the sheath, the delivery balloon catheter was damaged and the device was withdrawn.Subsequently, another 24 x 2.50 rebel stent was advanced; however, it was noted that the catheter broke about 25cm from the hub.The device was completely removed and the procedure was completed with a 2.5mm x 16mm rebel stent that was successfully deployed.No patient complications were reported and the patient was fine.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8376179
• Report Number: 2134265-2019-01760
• Device Sequence Number: 19165580
• Product Code: MAF
• UDI-Device Identifier: 08714729843900
• UDI-Public: 08714729843900
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 02/27/2019

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: 10/01/2020
• Device Model Number: 10274
• Device Catalogue Number: 10274
• Device Lot Number: 21200955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1