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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3520
Device Problems Entrapment of Device (1212); Material Deformation (2976)
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.
 
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.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter city: (b)(6).
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11206873
MDR Text Key227922227
Report Number2134265-2021-00466
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729195566
UDI-Public08714729195566
Combination Product (y/n)N
PMA/PMN Number
P900056
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 Date06/26/2022
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0025646222
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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