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

Model Number	H7493927412400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Deployed stent then went to pull stent balloon out.There was part of lesion that was expanded well and stent balloon got caught up in lesion and did not come out.Doctor then pulled delivery system out.Stent balloon left in coronary.

• Brand Name: REBEL¿
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7040478
• Report Number: 7040478
• Device Sequence Number: 16172437
• Product Code: MAF
• UDI-Device Identifier: 08714729843733
• UDI-Public: (01)08714729843733
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2017
• Report Date (Section F): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: H7493927412400
• Device Catalogue Number: H7493927412400
• Device Lot Number: 20361468
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Disability
• Patient Age: 74 YR
• Date Report Sent to FDA: 10/27/2017