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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 Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2023
Event Type  malfunction  
Event Description
It was reported that the device was difficult to remove.A guidezilla ii, 6f was selected for use.During the procedure, it was noted that the device could not be removed at stent.The procedure was completed with a different device.There were no complications reported and the patient was stable post procedure.
 
Event Description
It was reported that the device was difficult to remove.A guidezilla ii, 6f was selected for use.During the procedure, it was noted that the device could not be removed at stent.The procedure was completed with a different device.There were no complications reported and the patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.There was no sign of fluid to the device.There was severe tip damage to the device.Product analysis could not confirm the reported event, as the clinical circumstances could not be replicated.There was unreported severe tip damage to the device that could cause resistance during device advancement or removal.There is no indication that there were any issues/malfunction with the guide extension catheter that could have contributed to the reported event.The tip of the device was damaged, and the damage is indicative to what could occur during procedural use.
 
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Brand Name
GUIDEZILLA II
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key16975371
MDR Text Key316299096
Report Number2124215-2023-25277
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729939450
UDI-Public08714729939450
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1871
Device Catalogue Number1871
Device Lot Number0030880741
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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