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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 1871
Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

 
Event Description

It was reported that the stent became damaged within the guidezilla. A 3. 50 x 38 synergy drug-eluting stent and a 6f guidezilla ii guide catheter were advanced for use. However, during procedure, the stent was caught on the guidezilla and the stent strut was lifted. The devices were completely removed from the patient's body and the procedure was completed with another of the same device. No patient complications nor injuries were reported.

 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9957134
MDR Text Key187531386
Report Number2134265-2020-05033
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163314
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 05/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1871
Device Catalogue Number1871
Device LOT Number0023444496
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/06/2019
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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