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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 10272
Medical Device Problem Codes Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/06/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the mid right coronary artery.After engaging the lesion with a non-bsc guide extension catheter, a 16x4.00mm rebel stent was advanced for treatment.However, the device failed to cross the lesion and it was noted that the stent came off the balloon.No patient complications were 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 Key7791716
Report Number2134265-2018-60210
Device Sequence Number11214704
Product Code MAF
UDI-Device Identifier08714729843801
UDI-Public08714729843801
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P130030
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/18/2020
Device Model Number10272
Device Catalogue Number10272
Device Lot Number0021531961
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2018
Initial Report FDA Received Date08/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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