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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3240
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.A rotablator console kit was selected for use.Prior to procedure, the physician found the tube and decompression valve could not be connected.The procedure was not completed due to the event.The patient is stable, no patient complication or other additional intervention reported.
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
EP TECHNOLOGIES, INC.
150 baytech dr.
san jose CA 95134
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14517081
MDR Text Key292797702
Report Number2134265-2022-06026
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3240
Device Catalogue Number3240
Device Lot NumberRC402494
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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