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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 39467-125
Device Problem Entrapment of Device (1212)
Patient Problem Insufficient Information (4580)
Event Date 07/10/2023
Event Type  Injury  
Event Description
It was reported that the burr was stuck in the lesion, requiring additional intervention.A rotawire drive and a 1.25 rotapro were selected for use.During the procedure, it was noted that the burr could not advance on the wire.Furthermore, a kink was noted on the wire.The physician attempted to use another rotawire drive, however, the same issue occurred.It was then noted the rotapro burr was stuck in the lesion.The physician made several attempts to maneuver and remove the rotapro burr, but the rotapro burr could not be removed from the vessel.The procedure was cancelled, and the patient underwent emergency open-heart surgery to remove the device.
 
Event Description
It was reported that the burr was stuck in the lesion, requiring additional intervention.A rotawire drive and a 1.25 rotapro were selected for use.During the procedure, it was noted that the burr could not advance on the wire.Furthermore, a kink was noted on the wire.The physician attempted to use another rotawire drive, however, the same issue occurred.It was then noted the rotapro burr was stuck in the lesion.The physician made several attempts to maneuver and remove the rotapro burr, but the rotapro burr could not be removed from the vessel.The procedure was cancelled, and the patient underwent emergency open-heart surgery to remove the device.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotapro advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.Product analysis could not confirm the reported events, as the device was able to reach and maintain optimal rpm with no resistance or issues, no damages or defects contributing to the device becoming stuck in the lesion were identified, and the clinical circumstances could not be replicated.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17427930
MDR Text Key320076692
Report Number2124215-2023-39954
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/28/2023
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 Model Number39467-125
Device Catalogue Number39467-125
Device Lot Number0030639038
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2023
Initial Date FDA Received07/31/2023
Supplement Dates Manufacturer Received11/13/2023
Supplement Dates FDA Received11/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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