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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2023
Event Type  malfunction  
Event Description
It was reported that the fractured device was left in the patient and the procedure was cancelled.A rotawire 330cm and burr were selected for use.During the procedure, due to vessel tortuousity, the burr debulked the rotawire, then the wire broke and 5cm of the wire left in the vessel.A loop was used to retrieve the wire, but it was very difficult to retrieve the wire.The complaint was not completed due to this event.The physician arranged for surgery to be performed to remove the wire from the vessel.
 
Manufacturer Narrative
H6 evaluation conclusion codes: corrected.
 
Event Description
It was reported that the fractured device was left in the patient and the procedure was cancelled.A rotawire 330cm and burr were selected for use.During the procedure, due to vessel tortuousity, the burr debulked the rotawire, then the wire broke and 5cm of the wire left in the vessel.A loop was used to retrieve the wire, but it was very difficult to retrieve the wire.The complaint was not completed due to this event.The physician arranged for surgery to be performed to remove the wire from the vessel.
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18172744
MDR Text Key328559551
Report Number2124215-2023-63738
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/21/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received11/20/2023
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received11/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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