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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTA WIRE FLOPPY; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTA WIRE FLOPPY; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 0.009 IN X 330 CM
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/28/2015
Event Type  Injury  
Event Description
The patient had a highly calcified lesion to the right coronary artery.The patient procedure was to specifically use the rotablator to burr through lesion prior to stent.The rota wire floppy tip was across the lesion and in the process of using the burr, the tip of the rota wire completely broke off and a large section was left in the patient in the right coronary artery distal to the lesion.Numerous attempts were made to retrieve the wire by using various techniques.A cardiothoracic surgeon was consulted and the patient was taken to surgery to retrieve the wire.The surgeon was able to retrieve the wire in surgery but he was unable to by-pass the lesion due to the calcification of the artery.The patient was taken to the recovery room upon completion of the procedure.
 
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Brand Name
ROTA WIRE FLOPPY
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
one boston scientific place
natick MA 01760
MDR Report Key4500786
MDR Text Key20455878
Report Number4500786
Device Sequence Number1
Product Code MCX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number0.009 IN X 330 CM
Device Catalogue Number22824-002
Device Lot Number17157533
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/05/2015
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer02/10/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/05/2015
Patient Sequence Number1
Treatment
ROTA LINK PLUS WITH A 1.5 MM BURR
Patient Outcome(s) Other; Required Intervention;
Patient Age76 YR
Patient Weight77
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