• 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 PERIPHERAL ROTALINK PLUS CATHETER, PERIPHERAL, 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 PERIPHERAL ROTALINK PLUS CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29720
Device Problems Entrapment of Device (1212); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2019
Event Type  malfunction  
Event Description
It was reported the burr was stuck on wire. The target lesion was located in anterior tibial artery. A rotawire and 1. 25mm peripheral rotalink plus were selected for use. During the procedure, it was noted that the rotablator did not advance to the longer segment of the anterior tibial artery. The proximal section was successfully treated. When the device was removed, the burr would not pull back on the wire as it was stuck on the wire. The physician attempted to cut the catheter off the wire, however it could not come off. The device was removed as a unit and lost access as a result. Atherectomy of lower extremities was successful though it could not advance further. A balloon was put down and the artery was ballooned. No patient complications were reported and the patient was okay.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERIPHERAL ROTALINK PLUS
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8599600
MDR Text Key144704871
Report Number2134265-2019-05042
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/10/2021
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0023330108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-