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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 10287
Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2018
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.During preparation of a 16 x 3.50mm rebel stent, it was noted that the stent was not properly clipped.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 03:12 pm ct.The report number is being corrected from: 2134265-2018-64333to: 2134265-2018-60552.This report is follow-up # 1.
 
Event Description
It was reported that stent dislodgement occurred.During preparation of a 16 x 3.50mm rebel stent, it was noted that the stent was not properly clipped.The procedure was completed with another of the same device.No patient complications were reported.Device evaluated by mfr.: the outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed that the stent is damaged.The distal section of the stent looks stretched and the crimp marks are visible on the balloon.The proximal section is still tightly crimped onto the balloon.The tip is damaged and the balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the stent is damaged but appears to have possibly snagged on something and stretched.
 
Event Description
It was reported that the angiojet ultra system console failed the electrical safety test while conducting the annual preventative maintenance schedule.The angiojet ultra system console was plugged into the fluke safety tester for conducting annual preventative maintenance.The angiojet ultra system was not turned on.During the electrical safety test, the circuit breaker trips at the touch current failing the electrical safety test.No patient involved.The product was not returned for analysis.The device was inspected on site.It was noted that the rear metal plate of the angiojet ultra system had screws off and had to be attached to get correct earth reading.The electrical safety testing was repeated using the fluke meter and angiojet ultra system passed the testing.
 
Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 10:47 am ct.The report number is being corrected from: 2134265-2018-64113 to: 2134265-2018-60552.
 
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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
MDR Report Key7837410
MDR Text Key119034053
Report Number2134265-2018-60552
Device Sequence Number1
Product Code MAF
Combination Product (y/n)N
PMA/PMN Number
P980037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/21/2020
Device Model Number10287
Device Catalogue Number10287
Device Lot Number0020801251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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