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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1867
Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2020
Event Type  malfunction  
Event Description
It was reported that the device damaged a stent.The target lesion was located in the moderately calcified and mid thrombotic right coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the device was flat and bent.Subsequently, a non-bsc stent was damaged upon trying to advance through the guidezilla.The device was simply pulled out from the patient's body.The procedure was completed with a different device.No complications reported and patient was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual inspection revealed that the collar is separated, and the polytetrafluoroethylene (ptfe) is still holding the two ends together.There are multiple kinks along the hypotube.Microscopic inspection revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.
 
Event Description
It was reported that the device damaged a stent.The target lesion was located in the moderately calcified and mid thrombotic right coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the device was flat and bent.Subsequently, a non-bsc stent was damaged upon trying to advance through the guidezilla.The device was simply pulled out from the patient's body.The procedure was completed with a different device.No complications reported and patient was stable.
 
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Brand Name
GUIDEZILLA
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9933695
MDR Text Key186766084
Report Number2134265-2020-04463
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729839859
UDI-Public08714729839859
Combination Product (y/n)N
PMA/PMN Number
K123765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/08/2021
Device Model Number1867
Device Catalogue Number1867
Device Lot Number0024075593
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Date Manufacturer Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight70
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