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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
Lot Number RP001580
Device Problem Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2022
Event Type  malfunction  
Event Description
It was reported that the speed was unstable.A rotapro console was selected for use.During the procedure, the dynaglide rpm was at about 120,000 rpm and the normal rpm was unstable.Even after replacing the burr, the situation did not change and then the device was replaced with another of the same console.No patient complications reported.
 
Event Description
It was reported that the speed was unstable.A rotapro console was selected for use.During the procedure, the dynaglide rpm was at about 120,000 rpm and the normal rpm was unstable.Even after replacing the burr, the situation did not change and then the device was replaced with another of the same console.No patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Rotapro rp001580 failed final functional test step 5 offset normal mode minimum flow rate and it was at 111.933 schf.That failure impacted dynaglide which caused high rpm.The reported complaint was confirmed.Tested with the gold pneumatic kit in it and the console passed final functional test, replace pneumatic kit.Console failed visual inspection due to a misalignment/gap from the front panel.No other issues were identified during the product analysis.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
150 baytech dr.
san jose CA 95134
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16095246
MDR Text Key308175095
Report Number2124215-2022-55456
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P900056/S166
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 03/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberRP001580
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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