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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 39467-150
Device Problems Failure to Advance (2524); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2023
Event Type  malfunction  
Event Description
It was reported that the speed was unstable.A 1.50mm rotapro was selected for use.During the procedure and after performing ablation several times, the device failed to cross the lesion, so it was decided to adjust and increase the rotation speed to 180,000 with the rotation speed adjustment knob on the console.But there was no response at all.Eventually, the speed became unstable and suddenly increased by a time lag and reached 200,000 or more.Due to this event, the use of the device was discontinued, and the procedure was completed by replacing the device with another size.There was no patient injury reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The burr catheter was received attached to the advancer.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically 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 stalled and would not run.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled and the interior components were inspected for damages or defects.During destructive testing, it was identified that the turbine was corroded, indicating the presence of dried saline within the device.It was considered likely that the presence of dried saline interfered with the devices ability to rotate, leading to a device stall.Product analysis could not confirm the reported events, as the device was not able to rotate during analysis and clinical circumstances were unable to be replicated.
 
Event Description
It was reported that the speed was unstable.A 1.50mm rotapro was selected for use.During the procedure and after performing ablation several times, the device failed to cross the lesion, so it was decided to adjust and increase the rotation speed to 180,000 with the rotation speed adjustment knob on the console.But there was no response at all.Eventually, the speed became unstable and suddenly increased by a time lag and reached 200,000 or more.Due to this event, the use of the device was discontinued, and the procedure was completed by replacing the device with another size.There was no patient injury reported.
 
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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 Key17703668
MDR Text Key323221110
Report Number2124215-2023-45942
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 10/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39467-150
Device Catalogue Number39467-150
Device Lot Number0031781587
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2023
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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