Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 10/11/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.A rotablator console kit assy gen 230v was selected for use.The physician found that the connection of the cylinder pressure relief valve was loose when the device was prepared for the procedure.The procedure was not completed due to this event.After the on-site inspection, it was observed that the pressure relief valve was damaged.The issue was resolved after troubleshooting.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15727261
MDR Text Key305095912
Report Number2124215-2022-44364
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,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
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 NumberRC401581
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-