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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 3243
Device Problems Connection Problem (2900); Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It reported that there was unstable speed.A 1.5mm rotaro was selected for use an atherectomy procedure of the proximal left anterior descending (lad) artery.The rotapro was prepped and platformed at 165,000 rpm outside the patient.During the procedure, rotapro was advanced into the blood vessel and it was ablating between 164,000rpm -155,000rpm but there was a sudden increase in speed to 220,000rpm.After it was noted, the procedure was stopped and the burr was removed from the patient.The physician noticed the white fiberoptic connection was connected with the knob facing down.The physician turned the device on again with the knob down and it was 190,00rpm even though they had platformed out of the body at 165,00rpm.The speed could not be adjusted with the dial.When the advancer knob connecter was flipped up it was back at 163,000rpm and stayed in the correct range.The procedure was completed successfully with the same device.There were no patient complications reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a rotapro device.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined and no damage was found.Functional testing was performed by attempting to run the device; however, the device stalled.Additional testing was completed by attempting to rotate the drive shaft, however, it was unable to rotate due to the melted ultem.A melted ultem is due to the interruption of saline, by insufficient flow of saline used during the preparation or during the procedure of the device.Inspection of the remainder of the device presented no other damage or irregularities.A2: age at time of event: 18 years or older.
 
Event Description
It reported that there was unstable speed.A 1.5mm rotaro was selected for use an atherectomy procedure of the proximal left anterior descending (lad) artery.The rotapro was prepped and platformed at 165,000 rpm outside the patient.During the procedure, rotapro was advanced into the blood vessel and it was ablating between 164,000rpm -155,000rpm but there was a sudden increase in speed to 220,000rpm.After it was noted, the procedure was stopped and the burr was removed from the patient.The physician noticed the white fiberoptic connection was connected with the knob facing down.The physician turned the device on again with the knob down and it was 190,00rpm even though they had platformed out of the body at 165,00rpm.The speed could not be adjusted with the dial.When the advancer knob connecter was flipped up it was back at 163,000rpm and stayed in the correct range.The procedure was completed successfully with the same device.There were no patient complications reported and the patient's status was fine.
 
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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
MDR Report Key9553174
MDR Text Key177378511
Report Number2134265-2019-16378
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893363
UDI-Public08714729893363
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 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/30/2021
Device Model Number3243
Device Catalogue Number3243
Device Lot Number0024692196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Date Manufacturer Received02/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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