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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 10276
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 04/21/2020
Event Type  malfunction  
Event Description
It was reported that stent premature deployment occurred.A 32 x 3.00 rebel bms stent was selected for use.However, after opening the stent, it was noticed that the stent was already partially deployed.The device never entered the patient's body and the procedure was completed with another of the same device.
 
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Brand Name
REBEL
Type of Device
STENT, CORONARY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
500 commander shea boulevard
quincy MA 02171
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10057005
MDR Text Key191180922
Report Number2134265-2020-05613
Device Sequence Number1
Product Code MAF
UDI-Device Identifier08714729844068
UDI-Public08714729844068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/08/2020
Device Model Number10276
Device Catalogue Number10276
Device Lot Number0022221292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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