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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1873
Device Problems Entrapment of Device (1212); Obstruction of Flow (2423); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2020
Event Type  Malfunction  
Event Description

It was reported that the guidezilla was damaged at the distal tip due to resistance with a rotapro 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 NameGUIDEZILLA II
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9920915
MDR Text Key186549833
Report Number2134265-2020-04329
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2020
Device MODEL Number1873
Device Catalogue Number1873
Device LOT Number0022877453
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/14/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2018
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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