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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC - FREMONT (CE) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number H802220200381
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the rotation speed was unstable.The target lesion was located in the coronary artery.A rotablator rotational atherectomy system was selected for use.During testing, it was noted that the rotation speed was varying wildly between 8,000 to 242,000rpm before the burr was entered into the patient.Then, when the pedal was stepped, "stall" icon lit.They tried two burrs and two advancers but the same issue occurred.No patient complications were reported and the patient¿s condition was stable.
 
Event Description
It was reported that the rotation speed was unstable.The target lesion was located in the coronary artery.A rotablator rotational atherectomy system was selected for use.During testing, it was noted that the rotation speed was varying wildly between 8,000 to 242,000rpm before the burr was entered into the patient.Then, when the pedal was stepped, "stall" icon lit.They tried two burrs and two advancers but the same issue occurred.No patient complications were reported and the patient¿s condition was stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The foot pedal s/n (b)(4) passed the specifications for cis rotablator functional test.The rotablator console sn: (b)(4).Passed the specifications for cis rotablator functional test.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (CE)
47215 lakeview blvd
north dock
fremont CA 94538
MDR Report Key7656511
MDR Text Key113005437
Report Number2134265-2018-05819
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,foreig
Type of Report Initial,Followup
Report Date 06/12/2018
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 NumberH802220200381
Device Lot NumberRC401347
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Initial Date Manufacturer Received 06/20/2018
Initial Date FDA Received07/02/2018
Supplement Dates Manufacturer Received11/26/2018
Supplement Dates FDA Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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