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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 Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 12/16/2020
Event Type  Injury  
Event Description
It was reported that wire tip detachment occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified mid right coronary artery.A 330cm rotawire guidewire was selected for use.During the procedure, after ablation was completed using rotapro and the device was removed from the patient's body through dynaglide mode, the rotawire was exchanged for a workhorse wire.When it was tried to be removed, the rotawire advanced down a small branch off of the posterior lateral, buckling on itself and appeared to be knotted.Then, it broke at the buckle and the tip of the wire was broken off at 4mm distal to the weld.The burr was not rotating when the fracture occurred.The physician attempted to direct a snare down to retrieve it but was unsuccessful.The detached fragment approximately 18mm of the wire tip was left in the small branch of the posterior lateral because it could not be removed.The procedure was completed with a choice pt floppy wire.No complications were reported and the patient was fine post procedure.
 
Event Description
It was reported that wire tip detachment occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified mid right coronary artery.A 330cm rotawire guidewire was selected for use.During the procedure, after ablation was completed using rotapro and the device was removed from the patient's body through dynaglide mode, the rotawire was exchanged for a workhorse wire.When it was tried to be removed, the rotawire advanced down a small branch off of the posterior lateral, buckling on itself and appeared to be knotted.Then, it broke at the buckle and the tip of the wire was broken off at 4mm distal to the weld.The burr was not rotating when the fracture occurred.The physician attempted to direct a snare down to retrieve it but was unsuccessful.The detached fragment approximately 18mm of the wire tip was left in the small branch of the posterior lateral because it could not be removed.The procedure was completed with a choice pt floppy wire.No complications were reported and the patient was fine post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The returned guidewire had the spring tip broken and a section of approximately 0.5" is missing.The guidewire body has a kink approximately at 135cm from the proximal end.Dimensional inspection was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.
 
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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 Key11051416
MDR Text Key223052678
Report Number2134265-2020-18236
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729185871
UDI-Public08714729185871
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 02/26/2021
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
Device Expiration Date03/27/2022
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0025417988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Initial Date Manufacturer Received 12/16/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received02/11/2021
Supplement Dates FDA Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BURR - ROTAPRO; BURR - ROTAPRO; BURR - ROTAPRO
Patient Outcome(s) Required Intervention;
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