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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 Problems Break (1069); Entrapment of Device (1212); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2019
Event Type  malfunction  
Event Description
It was reported that the burr stripped the wire.A 1.5mm rotapro and a rotawire and wireclip torquer were selected for use.The physician performed rotational atherectomy which worked fine.Upon removing the rotapro burr from the patient in dynaglide mode, which was after the device was used to complete that portion of the procedure, the burr stripped and unraveled a portion of the wire.They were unsure how this issue occurred.The wire was stuck inside the rotapro.They removed the rotawire and rotapro as a unit.They placed in a new guide, inserted an unspecified balloon, and then stented the lesion with an unspecified stent.No further complications were reported.The patient condition was reported as well.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was returned.The guidewire had the body kinked in different sections; besides, the spring tip was kinked and a foreign matter was found stuck around the proximal end of the spring tip.No further device damage was noted.All dimensional analysis measurements of the device were within specification.
 
Event Description
It was reported that the burr stripped the wire.A 1.5mm rotapro and a rotawire and wireclip torquer were selected for use.The physician performed rotational atherectomy which worked fine.Upon removing the rotapro burr from the patient in dynaglide mode, which was after the device was used to complete that portion of the procedure, the burr stripped and unraveled a portion of the wire.They were unsure how this issue occurred.The wire was stuck inside the rotapro.They removed the rotawire and rotapro as a unit.They placed in a new guide, inserted an unspecified balloon, and then stented the lesion with an unspecified stent.No further complications were reported.The patient condition was reported as well.
 
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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 Key8577685
MDR Text Key143962761
Report Number2134265-2019-04772
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,health
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Date Manufacturer Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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