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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 Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter address 1:.
 
Event Description
It was reported that the procedure was cancelled.A rotablator console kit was selected for use.During the procedure, it was found that the supply hose was leaking at the connection to the device.The procedure was not completed because of this event.There were no complications reported and the patient was stable post procedure.
 
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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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16292542
MDR Text Key308749383
Report Number2124215-2023-02827
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
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2023
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 NumberRC403048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2023
Initial Date FDA Received02/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2021
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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