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

Model Number	1873
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidezilla was damaged and a balloon rupture occurred when the damaged part was crossed.A 15mmx2.75mm wolverine coronary cutting balloon and a 7f guidezilla catheter-guide extension were used.During the procedure, it was noted that the guidezilla is scratched and damaged and a balloon rupture has occurred when the damaged part was crossed.Consequently, it was confirmed through fluoroscopy that the collar part has collapsed toward the lumen side.The balloon and the guidezilla were removed without any problem.The procedure was completed with the guidezilla and another of the same balloon.No complications reported and the patient is in good condition after the procedure.
Event or Problem Description
It was reported that the guidezilla was damaged and a balloon rupture occurred when the damaged part was crossed.A 15mmx2.75mm wolverine coronary cutting balloon and a 7f guidezilla catheter-guide extension were used.During the procedure, it was noted that the guidezilla is scratched and damaged and a balloon rupture has occurred when the damaged part was crossed.Consequently, it was confirmed through fluoroscopy that the collar part has collapsed toward the lumen side.The balloon and the guidezilla were removed without any problem.The procedure was completed with the guidezilla and another of the same balloon.No complications reported and the patient is in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.There were numerous flat shaft segments to the device.An x-ray of the device was taken to see inside the collar area for any damages or irregularities.The x-ray presented the collar of the device with intact collar filar and was free of any damage or irregularity.Product analysis confirmed the device interaction as the numerous flat shaft segments would likely cause advancement issues.However, analysis could not confirm the reported collar damage as the x-ray showed there was no damage or irregularity to the collar.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16781020
• Report Number: 2124215-2023-18450
• Device Sequence Number: 6709415
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2023
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0027582057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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
• Patient Sex: Unknown