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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1867
Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2020
Event Type  Malfunction  
Event Description

It was reported that the device damaged a stent. The target lesion was located in the moderately calcified and mid thrombotic right coronary artery. A guidezilla guide extension catheter was selected for use. During procedure, it was noted that the device was flat and bent. Subsequently, a non-bsc stent was damaged upon trying to advance through the guidezilla. The device was simply pulled out from the patient's body. The procedure was completed with a different device. No complications reported and patient was stable.

 
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Brand NameGUIDEZILLA
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 Key9933695
MDR Text Key186766084
Report Number2134265-2020-04463
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1867
Device Catalogue Number1867
Device LOT Number0024075593
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 Manufactured07/09/2019
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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