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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3320
Device Problems Entrapment of Device (1212); Connection Problem (2900); Output Problem (3005); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2020
Event Type  malfunction  
Event Description
It was reported that there was difficulty removing the device.A 1.50mm rotapro and rotawire were selected for use with a guidezilla in a heavily calcified lesion in the mid-right coronary artery (rca), with significant calcified lesions in the distal rca.Of note, there was a calcific tortuous lesion in the proximal rca with previously implanted stents mid-segment.During the procedure, the rotapro decelerated and became stalled in the mid-rca.Dynaglide mode was activated however, when the burr exited the distal lumen of the guidezilla, the rotapro stalled against the hypotube of the catheter.The burr was attempted to be removed over the wire manually, but it was unable to be done so the burr and wire were removed from the patient body together.Upon inspection after removal it was discovered that the distal tip of the guidezilla was damaged due to friction between the guidezilla and rotapro shaft.A 1.75mm rotapro and new rotawire were selected to continue the case, and advanced to the mid-rca where the device experienced unstable speed issues.The physician was unable to remove the device using the advancer knob.The system did not stall and when activated would rotate at 200 rpms and the system made a different sound than usual.It was identified that the connection failed, and the system was removed from the patient.The procedure was completed using an alternative method.Post procedure, a good angiographic result was achieved.No patient complications were reported and patient was reported as well at the end of the procedure.
 
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Brand Name
ROTALINK BURR
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9922641
MDR Text Key186545575
Report Number2134265-2020-04392
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729185840
UDI-Public08714729185840
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/03/2020
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
Device Operator Health Professional
Device Expiration Date07/23/2021
Device Model Number3320
Device Catalogue Number3320
Device Lot Number0024317288
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2020
Initial Date FDA Received04/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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