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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
Device Problem Entrapment of Device (1212)
Patient Problem Stroke/CVA (1770)
Event Date 09/10/2020
Event Type  Injury  
Event Description
It was reported that the burr became stuck on the guidewire and a stroke occurred.A 1.25mm rotalink plus with rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.During the procedure, the burr became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together as one unit from the patient.The patient was transferred to emergency surgery and received a coronary artery bypass grafting (cabg).Then, the patient had a stroke.
 
Manufacturer Narrative
Device evaluated by manufacturer: the rotalink plus and rotawire were returned for analysis.The wire was able to be removed with some minor resistance from the rotalink plus.There were numerous kinks along the body of the rotawire.The overall length and outer diameters of the distal tip, middle, and proximal sections of the device were within specification.
 
Event Description
It was reported that the burr became stuck on the guidewire and a stroke occurred.A 1.25mm rotalink plus with rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.During the procedure, the burr became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together as one unit from the patient.The patient was transferred to emergency surgery and received a coronary artery bypass grafting (cabg).Then, the patient had a stroke.
 
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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 Key10671528
MDR Text Key211087407
Report Number2134265-2020-14041
Device Sequence Number1
Product Code MCX
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,foreig
Type of Report Initial,Followup
Report Date 11/18/2020
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 Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/13/2020
Supplement Dates Manufacturer Received11/17/2020
Supplement Dates FDA Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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