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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 Consequences Or Impact To Patient (2199)
Event Date 11/03/2020
Event Type  malfunction  
Event Description
It was reported that the burr was unable to retract over the wire. The target lesion was located in the severely calcified superficial femoral artery (sfa). A 2. 00mm peripheral rotalink plus and a peripheral rotawire were selected for use. During procedure, the burr stalled on two occasions. Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire. The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion. A new access was obtained and successful angioplasty was performed to complete procedure. There were no patient complications reported.
 
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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 Key10875423
MDR Text Key217336805
Report Number2134265-2020-16161
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 11/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number29720
Device Catalogue Number29720
Device Lot Number0026074783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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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