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 ROTAWIRE ELITE AND WIRECLIP TORQUER; 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 ROTAWIRE ELITE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Device Problems Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that shavings came out from the burr.A rotawire was selected for use.During preparation, resistance was encountered when inserting the rotawire into the rotaburr.Subsequently, objects like shavings came out from the tip of the burr.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that shavings came out from the burr.A rotawire was selected for use.During preparation, resistance was encountered when inserting the rotawire into the rotaburr.Subsequently, objects like shavings came out from the tip of the burr.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the returned device had the distal tip bent.No more damages were encountered in the device.Dimensional inspections were measured for the overall length, outer diameter of distal tip, outer diameter of the middle of the device and the outer diameter of the proximal section and were within specification.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTAWIRE ELITE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8798407
MDR Text Key151305214
Report Number2134265-2019-08334
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/02/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Initial Date Manufacturer Received 06/20/2019
Initial Date FDA Received07/17/2019
Supplement Dates Manufacturer Received09/11/2019
Supplement Dates FDA Received10/02/2019
Patient Sequence Number1
-
-