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

Model Number	10274
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of a rebel bms catheter in two pieces.The balloon was loosely folded with the stent secured between the markerbands.The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.The hypotube was completely separated 26.3cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The proximal end of the stent is damaged.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 08 mar 2019.It was reported that shaft damage 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selected for use.However, upon passing through the sheath, the delivery balloon catheter was damaged and the device was withdrawn.Subsequently, another 24 x 2.50 rebel stent was advanced; however, it was noted that the catheter broke about 25cm from the hub.The device was completely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.However, returned device analysis revealed hypotube detached/separated and stent damage.

• Brand Name: REBEL
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8469298
• Report Number: 2134265-2019-03231
• Device Sequence Number: 1633700
• 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): 04/01/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1