MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP REBEL; MONORAIL PLATINUM CHROMIUM CORONARY STENT

Catalog Number	H7493927412450
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During lmt, angioplasty balloon from rebel monorail platinum chromium coronary stent system broke and was lodged in lmt.The balloon was not able to be removed percutaneously requiring open heart surgery to remove the balloon.After the balloon was deflated, the physician could not pull it out of the deployed stent.After pulling on the shaft of the balloon in a final attempt, the catheter broke.

• Brand Name: REBEL
• Common Device Name: MONORAIL PLATINUM CHROMIUM CORONARY STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; marlborough MA
• MDR Report Key: 7013186
• Report Number: 7013186
• Device Sequence Number: 1423805
• Product Code: MAF
• UDI-Device Identifier: 08714729843740
• UDI-Public: 08714729843740
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/31/2017
• Report Date (Section F): 10/31/2017

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: 02/29/2020
• Device Catalogue Number: H7493927412450
• Device Lot Number: 20232912
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 96