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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 Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.A 6f guidezilla ii guide extension catheter was selected for use however, it was noted that there was resistance inside the guiding catheter.The procedure was cancelled.No patient complications were reported.
 
Event Description
It was reported that the procedure was cancelled.A 6f guidezilla ii guide extension catheter was selected for use however, it was noted that there was resistance inside the guiding catheter.The procedure was cancelled.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Microscopic and visual inspection revealed numerous kinks in the shaft.Inspection of the rest of the device found no other damage or defect.The outer diameter (od) of the shaft was measured with a calibrated micrometer.The undamaged od measured.066 inch, meeting the specification and the damaged od of the shaft measured.082 inch, exceeding the specification.Device to device testing was carried out by inserting the tip of the guidezilla into the hub of the guide catheter and advancing.The guidezilla advanced in the returned guide for 7.6cm and then stopped.The shaft stopped advancing at the location of the first kink.
 
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Brand Name
GUIDEZILLA II
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10514799
MDR Text Key206332180
Report Number2134265-2020-12595
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729939450
UDI-Public08714729939450
Combination Product (y/n)N
PMA/PMN Number
K163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/15/2021
Device Model Number1871
Device Catalogue Number1871
Device Lot Number0024948729
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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