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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II LONG GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939335150610
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

Same case as mdr id: 2134265-2018-05620. It was reported that interaction with another device during withdrawal occurred. The target lesion was located in a coronary artery. A 6f guidezilla¿ ii long guide extension catheter was in use while a 3. 50 x 32 synergy ii drug-eluting stent was advanced for treatment. When the physician attempted to remove the stent, it was snagged by the guidezilla¿ and became unusable. No patient complications were reported and the patient's status was fine.

 
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Brand NameGUIDEZILLA¿ II LONG 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 Key7631023
MDR Text Key112293613
Report Number2134265-2018-05633
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 05/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/02/2020
Device MODEL NumberH74939335150610
Device LOT Number22078171
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/04/2018
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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