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 ROTALINK PLUS; 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 ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3241
Medical Device Problem Codes Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event or Problem Description
It was reported that a burr became stuck on the rotawire.A 2.00mm rotalink plus and a rotawire were selected for use.During the procedure, when delivering the burr to the lesion, resistance was noted.Consequently, the physician attempted to remove the burr; however, it could not be pulled and was trapped and unusual sound was heard.Then, the burr was removed together with the rotawire.The procedure was completed with a 1.75mm rotalink plus and new rotawire.No patient complications were reported and the patient's status was good.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTALINK PLUS
Common Device Name
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8408641
Report Number2134265-2019-02258
Device Sequence Number13906073
Product Code MCX
UDI-Device Identifier08714729316442
UDI-Public08714729316442
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P900056
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/11/2019
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
Operator of Device Health Professional
Device Expiration Date09/14/2020
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0022791955
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ROTAWIRE ELITE AND WIRECLIP TORQUER
-
-