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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 Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion area was located in the coronary artery.A 2.00mm x 12mm maverick balloon catheter was advanced for dilation along with a 145, 5-in-6 guidezilla extension guide catheter.However, during the procedure the balloon was gashed by the extension catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that balloon rupture occurred.The target lesion area was located in the coronary artery.A 2.00mm x 12mm maverick balloon catheter was advanced for dilation along with a 145, 5-in-6 guidezilla extension guide catheter.However, during the procedure the balloon was gashed by the extension catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, distal shaft, collar, and hypotube included microscopic and visual inspection.Inspection revealed a complete separation of the collar/shaft with the polytetrafluoroethylene (ptfe) completely pulled out of the collar, and the tip was slightly damage (flared).Inspection of the rest of the device found no other damage or defect to the device.The inner diameter of the tip of the device and collar were measured with a calibrated pin gage.Both the tip and the collar measured.057", meeting the specification.The guidezilla catheter was separated at the collar/shaft connection, so functional testing with a balloon catheter was not possible.
 
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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 Key10020953
MDR Text Key190144222
Report Number2134265-2020-05933
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,foreig
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0024075596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Initial Date Manufacturer Received 04/17/2020
Initial Date FDA Received05/04/2020
Supplement Dates Manufacturer Received06/05/2020
Supplement Dates FDA Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2.00MM X 12MM MAVERICK BALLOON; 2.00MM X 12MM MAVERICK BALLOON
Patient Age64 YR
Patient Weight68
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