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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 3259
Device Problems Failure to Shut Off (2939); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that the burr became stuck in the lesion and the console failed to deactivate the power.The 90% stenosed target lesion was moderately tortuous and moderately calcified circumflex artery.A 1.50mm rotapro and rotapro console were selected in the for use in the rotablation procedure.The rotapro was prepped and platformed at 160,000rpm outside the patient then advanced over the wire.A pecking motion was used for advancement and rotapro was advanced into the lesion.During procedure, the rotation speed was 160,000rpm, the burr became stuck in the lesion, stalled and the console would not turn off.The physician unplugged the rotapro device from the console, then burr was then the rotawire tip was used to pull the burr out of the lesion.The rotapro and the rotawire were removed together as one unit from the patient.The procedure was completed successfully with balloons.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was not received at the complaint investigation site (cis) for analysis.Analysis of the alleged rotapro console and rotapro device were performed by boston scientific engineers at the went onsite to (b)(6) hospital in (b)(6) on (b)(6) 2021.Rotapro console and rotapro 1.5mm advancer were investigated.Inspection of the rotapro console showed no signs of loose components or damage.Using the rotapro console and rotapro advancer involved in the case, the advancer starts up but showed low and erratic speeds on the rotapro console display without audible rotation pitch change.The ends of the fiber optic lines were checked by removing the fiber optic connector from the advancer turbine housing.Dried saline was identified to by attenuating the fiber optic signal.The end of the fiber optic line was cleaned and reseated into the advancer turbine housing and the advancer turned on within expected start up speed.All rotapro advancer buttons work as expected.Deceleration events were simulated by applying pressure to the burr with a wet towel.During these deceleration events, the on/off button worked as expected.The four second on/off button depress where the on/off mode will not change was verified to be operating as expected.The failure mode of the rotapro advancer failing to turn off from an on state was not reproduced.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 was reported that the burr became stuck in the lesion and the console failed to deactivate the power.The 90% stenosed target lesion was moderately tortuous and moderately calcified circumflex artery.A 1.50mm rotapro and rotapro console were selected in the for use in the rotablation procedure.The rotapro was prepped and platformed at 160,000rpm outside the patient then advanced over the wire.A pecking motion was used for advancement and rotapro was advanced into the lesion.During procedure, the rotation speed was 160,000rpm, the burr became stuck in the lesion, stalled and the console would not turn off.The physician unplugged the rotapro device from the console, then burr was then the rotawire tip was used to pull the burr out of the lesion.The rotapro and the rotawire were removed together as one unit from the patient.The procedure was completed successfully with balloons.There were no patient complications reported.
 
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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 Key12342814
MDR Text Key267282010
Report Number2134265-2021-10571
Device Sequence Number1
Product Code MCX
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 10/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3259
Device Catalogue Number3259
Device Lot NumberRP000809
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/19/2021
Supplement Dates Manufacturer Received09/21/2021
Supplement Dates FDA Received10/09/2021
Patient Sequence Number1
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