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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H7493933515060
Device Problem Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that the tip of the guidezilla got split. A guidezilla¿ ii guide extension catheter was selected for use during a stent placement procedure in a calcified proximal vessel. During procedure, when the guidezilla ii was removed from the guide, because it would not advance any further, it was noted that the atraumatic tip of the guidezilla ii split. The procedure was completed with another of the same device without any issues. No patient complications were reported and the patient¿s status was good.

 
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Brand NameGUIDEZILLA¿ II GUIDE EXTENSION CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7626340
MDR Text Key112054473
Report Number2134265-2018-05823
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 06/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/09/2020
Device MODEL NumberH7493933515060
Device LOT Number21971890
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2018
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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