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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2022
Event Type  malfunction  
Event Description
It was reported that the burr unintentionally moved within the lesion.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left proximal circumflex artery.A 1.25mm rotapro was selected for use.During the procedure, the advancer knob did not move smoothly after turning to a high-speed rotation.When the pushing force was applied on the knob, the burr suddenly moved forward.The device was removed as usual.The procedure was completed with another of same device.No patient complications and injury were reported.
 
Manufacturer Narrative
Initial facility name - (b)(6).
 
Event Description
It was reported that the burr unintentionally moved within the lesion.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left proximal circumflex artery.A 1.25mm rotapro was selected for use.During the procedure, the advancer knob did not move smoothly after turning to a high-speed rotation.When the pushing force was applied on the knob, the burr suddenly moved forward.The device was removed as usual.The procedure was completed with another of same device.No patient complications and injury were reported.
 
Manufacturer Narrative
E1: initial facility name - saitama prefectural cardiovascular and respiratory center device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated with no issues.The advancer knob was able to be moved back and forth with no resistance prior to rotational testing.The rotapro advancer was then connected to the rotapro control console system.The knob switch (ablation button) turned on when the button was pushed and was able to reach optimal speed without dropping speed without any issues.The advancer knob was moved forwards and backwards during test rotation, and no abnormalities or jumps were identified.Product analysis did not confirm the reported event, as the device was able to reach and maintain optimal speed with no issues and there were no abnormalities or jumps identified when the advancer knob was moved back and forth during test rotation.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16126448
MDR Text Key308110220
Report Number2124215-2023-00166
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public8714729893356
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39467-125
Device Catalogue Number39467-125
Device Lot Number0029968321
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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