• 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 Output Problem (3005); Intermittent Loss of Power (4016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2020
Event Type  malfunction  
Event Description
It was reported that the device speed exceeds the set operational speed. Vascular access was obtained via dorsalis pedis using a 4f/5f non-boston scientific device. The target lesion was located at the right anterior tibial artery. A 1. 25mm peripheral rotalink plus was selected for use. During procedure, the burr was advanced into the mid calf and fist pass was attempted but the device stalled. Subsequently, the device was backed up using dynaglide approximately 2cm and tried again, and once again the device stalled in the same location. Another attempt was made but the same thing happened. At this point, the device was removed using dynaglide and proceeded to complete the procedure using balloon angioplasty only. However, it was further noted that the maximum speed the device reached was 202,000rpm which exceeds the set operational speed of 200,000rpm. There were no complications reported and the patient did well.
 
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
model farm road
cork
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10778349
MDR Text Key214350173
Report Number2134265-2020-15115
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,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0025949273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-