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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 3560
Device Problem Device Damaged by Another Device (2915)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 05/19/2020
Event Type  Injury  
Event Description
It was reported that tip detachment occurred.A rotawire and 1.5mm rotapro were selected to treat the non-tortuous target lesion in the svg to rca.During the procedure the rotawire tip detached.The detached tip was successfully retrieved via a snare and no patient harm occurred.The procedure was successfully completed.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned.The returned guidewire had the spring tip completely stretched.The core wire was measured and it had a length of approximately 328.3 cm from the proximal end which means it was not complete, it should measure 330 cm; the detached section was not returned.No more visual damages were encountered in the device.The outer diameter of the measurable middle and proximal sections of the device were within specification.
 
Event Description
It was reported that tip detachment occurred.A rotawire and 1.5mm rotapro were selected to treat the non-tortuous target lesion in the svg to rca.During the procedure the rotawire tip detached.The detached tip was successfully retrieved via a snare and no patient harm occurred.The procedure was successfully completed.
 
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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 Key10115425
MDR Text Key193691398
Report Number2134265-2020-07467
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729144168
UDI-Public08714729144168
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 06/30/2020
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
Device Expiration Date08/27/2021
Device Model Number3560
Device Catalogue Number3560
Device Lot Number0024341869
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Initial Date Manufacturer Received 05/19/2020
Initial Date FDA Received06/03/2020
Supplement Dates Manufacturer Received06/25/2020
Supplement Dates FDA Received06/30/2020
Patient Sequence Number1
Treatment
1.5MM ROTAPRO ATHERECTOMY; 1.5MM ROTAPRO ATHERECTOMY; 1.5MM ROTAPRO ATHERECTOMY
Patient Outcome(s) Required Intervention;
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