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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Lot Number 0032808199
Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2024
Event Type  malfunction  
Event Description
It was reported that the burr was stuck on the guidewire.During a tibial atherectomy procedure, the 90% stenosed target lesion was located in the mildly tortuous and moderately calcified artery.A 1.50mm rotapro burr-advancer and rotawire were selected for use.During the procedure, the speed was set to 170k rpm and was able to make two successful passes, dropping 5k rpm each pass.After the second pass, the device stopped upon retraction of the burr, proximal to the lesion and displayed a stall error.Resolution was attempted by sliding the burr back and forth and it appeared that it was stuck on the wire.The entire device was pulled back several centimeters on the wire, and the burr moved smoothly back and forth from it however, the device still displayed a stall error.A gas reading was verified, displaying 1500 psi in the tank and it was adjusted to 100 psi output to the burr.The device was completely removed.An out of body test was completed, in addition to a complete console set shutdown and restart, however the stall error still occurred.The procedure was completed with another of the same device.No patient complications were reported.
 
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 found that the coil was kinked and stretched at the handshake connection.Functional testing was performed by connecting the device to the rotapro console control system.When the knob switch (ablation button) was pressed, the device stalled and would not run due to the damaged coil.Further functional testing was performed using a test rotawire, as the rotawire used in the procedure was not returned.During testing, the rotawire was able to be inserted through the annulus but was not able to pass the damage to the coil.Product analysis confirmed the reported events, as the coil was kinked and stretched, causing the device to stall and preventing insertion of the rotawire.It was considered likely that the resistance between the rotawire and the device during the procedure was attributable to the damaged coil.
 
Event Description
It was reported that the burr was stuck on the guidewire.During a tibial atherectomy procedure, the 90% stenosed target lesion was located in the mildly tortuous and moderately calcified artery.A 1.50mm rotapro burr-advancer and rotawire were selected for use.During the procedure, the speed was set to 170k rpm and was able to make two successful passes, dropping 5k rpm each pass.After the second pass, the device stopped upon retraction of the burr, proximal to the lesion and displayed a stall error.Resolution was attempted by sliding the burr back and forth and it appeared that it was stuck on the wire.The entire device was pulled back several centimeters on the wire, and the burr moved smoothly back and forth from it however, the device still displayed a stall error.A gas reading was verified, displaying 1500 psi in the tank and it was adjusted to 100 psi output to the burr.The device was completely removed.An out of body test was completed, in addition to a complete console set shutdown and restart, however the stall error still occurred.The procedure was completed with another of the same device.No patient complications were reported.
 
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Type of Device
CATHETER, PERIPHERAL, 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 Key18640764
MDR Text Key334723967
Report Number2124215-2024-04788
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032808199
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2023
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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