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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29720
Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Event Description
It was reported that the burr was stuck in the lesion. The 100% stenosed target lesion was located in the moderate to severely calcified distal post tibial artery. A 1. 50mm peripheral rotalink plus was selected for use. During the procedure, the device entered the target lesion and stalled out. It would not start spinning again and would not advance forward or backward with use of the advancer knob. It was noted that the burr was stuck in the lesion. The physician pulled the entire catheter back and the device was freed and was able to spin again outside the patient's body. Physician did not re-deliver the device as the stenosis was too tight and calcified. It was then treated by percutaneous transluminal angioplasty and the procedure was completed without performing rotablation. No complications were reported and the patient was fine post procedure.
 
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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 Key11359197
MDR Text Key233051080
Report Number2134265-2021-02131
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 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0026079033
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 Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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