MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II; CATHETER, PERCUTANEOUS

Model Number	1873
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an air embolism occurred.The target lesion was located in the severely calcified artery.A guidezilla ii, 7f guide extension catheter was selected for use.During a percutaneous coronary intervention (pci) procedure, it was noted that a non-bsc balloon catheter, stent, and y-shaped connector's deliverability for lesion was poor, orbital atherectomy system (oas) was delivered using guidezilla up to left main coronary artery segment os.After that time, the pressure became dull, and when the blood was reversed (drawing blood with a syringe), air got mixed in.When the non-bsc balloon catheter delivered using the guidezilla in the same way, the same issue occurred, as well as in delivering the non-bsc stent.The procedure was completed with the original device.There patient was in good condition post procedure.
Additional Manufacturer Narrative
F10 & h6.Device code - updated.H1.Corrected from malfunction report to serious injury.
Event or Problem Description
It was reported that an air embolism occurred.The target lesion was located in the severely calcified artery.A guidezilla ii, 7f guide extension catheter was selected for use.During a percutaneous coronary intervention (pci) procedure, it was noted that a non-bsc balloon catheter, stent, and y-shaped connector's deliverability for lesion was poor, orbital atherectomy system (oas) was delivered using guidezilla up to left main coronary artery segment os.After that time, the pressure became dull, and when the blood was reversed (drawing blood with a syringe), air got mixed in.When the non-bsc balloon catheter delivered using the guidezilla in the same way, the same issue occurred, as well as in delivering the non-bsc stent.The procedure was completed with the original device.There patient was in good condition post procedure.
Additional Manufacturer Narrative
F10 & h6.Device code - updated.H1.Corrected from malfunction report to serious injury.The device was returned and evaluated by manufacturer.Visual and microscopic inspection revealed no damage or irregularity.There was no sign of fluid to the device.The stent delivery system was able to be inserted into collar and advanced through the shaft and out the tip of the device with no resistance or issue.
Event or Problem Description
It was reported that an air embolism occurred.The target lesion was located in the severely calcified artery.A guidezilla ii, 7f guide extension catheter was selected for use.During a percutaneous coronary intervention (pci) procedure, it was noted that a non-bsc balloon catheter, stent, and y-shaped connector's deliverability for lesion was poor, orbital atherectomy system (oas) was delivered using guidezilla up to left main coronary artery segment os.After that time, the pressure became dull, and when the blood was reversed (drawing blood with a syringe), air got mixed in.When the non-bsc balloon catheter delivered using the guidezilla in the same way, the same issue occurred, as well as in delivering the non-bsc stent.The procedure was completed with the original device.There patient was in good condition post procedure.

• Brand Name: GUIDEZILLA II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18788693
• Report Number: 2124215-2024-10065
• Device Sequence Number: 18228671
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2025
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0032187015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/22/2024; 04/15/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/08/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown