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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 Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2017
Event Type  Malfunction  
Manufacturer Narrative

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

Same case as mdr id: 2134265-2017-13031. It was reported that stent dislodgement occurred. A 6f guidezilla¿ ii guide extension catheter and a 4. 00 x 24 synergy¿ stent were selected for a complex coronary angioplasty procedure. The synergy¿ stent became dislodged into the guidezilla¿ ii catheter when it came into contact with the calcification. It was not possible to remove the stent from the catheter. It was necessary to remove the devices together. The procedure was completed with another stent and catheter. There were no clinical consequences for the patient.

 
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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 Key7141823
MDR Text Key95643053
Report Number2134265-2017-13173
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK163314
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 12/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/23/2019
Device MODEL NumberH7493933515060
Device LOT Number21047070
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/05/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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