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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 Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2020
Event Type  Malfunction  
Event Description

It was reported that balloon rupture occurred. The target lesion area was located in the coronary artery. A 2. 00mm x 12mm maverick balloon catheter was advanced for dilation along with a 145, 5-in-6 guidezilla extension guide catheter. However, during the procedure the balloon was gashed by the extension catheter. The procedure was completed with a different device. No patient complications were reported and the patient's status 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 Key10020953
MDR Text Key190144222
Report Number2134265-2020-05933
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,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2020
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 Number0024075596
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/12/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
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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