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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY
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BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY Back to Search Results
Model Number 10275
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event or Problem Description
It was reported that stent dislodgement outside patient occurred.A 28 x 4.50 rebel bms stent was advanced for use.However, stent was off the balloon when it came out from the package.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
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Brand Name
REBEL
Common Device Name
STENT, CORONARY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11273442
Report Number2134265-2021-00739
Device Sequence Number17200773
Product Code MAF
UDI-Device Identifier08714729844020
UDI-Public08714729844020
Combination Product (Y/N)N
Initial Reporter StateSD
Initial Reporter CountryUS
PMA/510(K) Number
P130030
Number of Events Summarized1
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
Report Date (Section B) 02/03/2021
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 Date07/13/2023
Device Model Number10275
Device Catalogue Number10275
Device Lot Number0025703945
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/15/2021
Initial Report FDA Received Date02/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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