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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Catalog Number H802227680020
Device Problems Bent (1059); Break (1069)
Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)
Event Date 06/06/2016
Event Type  Death  
Event Description
A patient with very diseased vessels was undergoing a percutaneous coronary intervention of the right coronary artery to reduce a lesion.When the radiologist maneuvered the burr catheter in place and began to drill, it felt like drilling into cement.The catheter bent over itself because the lesion was so dense.As the device twisted, the burr broke at the tip and embolized.The catheter was removed from the patient but the burr tip remained in the patient.There was no autopsy performed so it is unclear specifically how the burr tip contributed to the death of this patient.
 
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Brand Name
ROTALINK BURR
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key5846414
MDR Text Key51152132
Report Number5846414
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Expiration Date03/03/2018
Device Catalogue NumberH802227680020
Device Lot Number19150639
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2016
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer06/15/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age88 YR
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