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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 39467-150
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the rotaburr became stuck with the rotawire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 330cm rotawire and a rotablator were selected for use.During removal, it was noted that the rotaburr got stuck with the rotawire.The rotaburr was not released from being stuck.The rotaburr was removed from the body together with the rotawire.There was a visible kink on the rotawire.The devices were not able to be separated without difficulties while outside the patient.The procedure was completed with the original device.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter facility name:(b)(6) hospital.E1 - initial reporter city: (b)(6).
 
Event Description
It was reported that the rotaburr became stuck with the rotawire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 330cm rotawire and a rotablator were selected for use.During removal, it was noted that the rotaburr got stuck with the rotawire.The rotaburr was not released from being stuck.The rotaburr was removed from the body together with the rotawire.There was a visible kink on the rotawire.The devices were not able to be separated without difficulties while outside the patient.The procedure was completed with the original device.No patient complications were reported.It was further reported that a 1.50mm rotapro was used during the procedure.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11206821
MDR Text Key227925391
Report Number2134265-2021-00469
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/25/2021
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
Device Operator Health Professional
Device Expiration Date06/18/2022
Device Model Number39467-150
Device Catalogue Number39467-150
Device Lot Number0025613438
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/07/2021
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received01/21/2021
Supplement Dates FDA Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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