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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2023
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled due to pedal leaking gas.A ce rotablator was selected for use.During the procedure, it was noted that the pedal was leaking gas, the procedure was cancelled because of this.No patient complications were reported.
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
EP TECHNOLOGIES, INC.
150 baytech dr.
san jose CA 95134
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16974205
MDR Text Key315668428
Report Number2124215-2023-25300
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/22/2023
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 Number3240
Device Catalogue Number3240
Device Lot NumberRC402506
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2023
Initial Date FDA Received05/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2019
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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