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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 1873
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 08/29/2019
Event Type  malfunction  
Event Description
It was reported that the sterile bag was not completely sealed.A 7f guidezilla ii was selected for use.During preparation, it was observed that the bottom part of the sterile bag was not sealed.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that the sterile bag was not completely sealed.A 7f guidezilla ii was selected for use.During preparation, it was observed that the bottom part of the sterile bag was not sealed.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The shelf box and product pouch were visually inspected.Visual inspection revealed that the seal on the shelf box is open.The pouch was taken out and visually inspected and the bottom of the pouch is not sealed.Inspection of the remainder of the device presented no damage or irregularities.
 
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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 Key9098189
MDR Text Key159420061
Report Number2134265-2019-11467
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729939474
UDI-Public08714729939474
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 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/27/2020
Device Model Number1873
Device Catalogue Number1873
Device Lot Number0023257087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Date Manufacturer Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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