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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 3256
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled post patient sedation.A rotapro console was selected for use.During preparation after the patient was sedated, the middle electrical connection inside the input was found to be broken.There were no patient complications.However, the procedure was not completed.
 
Event Description
It was reported that the procedure was cancelled post patient sedation.A rotapro console was selected for use.During preparation after the patient was sedated, the middle electrical connection inside the input was found to be broken.There were no patient complications.However, the procedure was not completed.
 
Manufacturer Narrative
Device eval by manufacturer: the rotapro console serial number (b)(6) was returned for analysis.The unit was received back with an approximate 1 inch scratch in the middle of the screen.The electrical connector was chipped and completely loose.The front housing was replaced, which resolved the issue.
 
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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 Key10522153
MDR Text Key206545296
Report Number2134265-2020-12650
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729975076
UDI-Public08714729975076
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 12/17/2020
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 Number3256
Device Catalogue Number3256
Device Lot NumberRP000393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2020
Initial Date Manufacturer Received 09/02/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received12/14/2020
Supplement Dates FDA Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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