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

Model Number	H74939335150610
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the collar was damaged.The severely vascular stenosed target lesion was located in a 90% of tortuous and severely calcified left circumflex artery.A 6f long guidezilla ii catheter-guide extension was selected for percutaneous coronary intervention (pci).During the procedure, it was noted that the metal connection part between the short transition section of the hypotube and the visible spiral sleeve ring was kinked and could not cross a non-boston scientific stent.The device was removed from the patient using a balloon-anchored guidewire.The procedure was completed with another of the same device.There were no patient complications reported, the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1 and phone: (b)(6).Investigation results: media review: during the media analysis, the media attached to the parent record does not show evidence of the reported issues, therefore, it does not confirm the reported allegations.Additionally, the media attached shows the tip flattened.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of no problem detected following a review of media, reported event details, available information, and product record review.In this case, no damage was found in media inspection that could have contributed to the reported allegations.Also, the batch record review concluded that no manufacturing deviations were identified during the manufacturing process that could have contributed to the complaint.Regarding the observed tip flattened and the additional device required, this can occur during the procedure due to the advancement maneuvers.Based on analysis and the reported information, the reported event likely occurred as a result of factors encountered during the procedure of which can include handling of the device.Therefore, adverse event related to procedure is the assigned cause for the encountered tip flattened and the additional device required.
Event or Problem Description
It was reported that the collar was damaged.The severely vascular stenosed target lesion was located in a 90% of tortuous and severely calcified left circumflex artery.A 6f long guidezilla ii catheter-guide extension was selected for percutaneous coronary intervention (pci).During the procedure, it was noted that the metal connection part between the short transition section of the hypotube and the visible spiral sleeve ring was kinked and could not cross a non-boston scientific stent.The device was removed from the patient using a balloon-anchored guidewire.The procedure was completed with another of the same device.There were no patient complications reported, the patient was stable 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24757281
• Report Number: 2124215-2026-17943
• Device Sequence Number: 9229727
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)260925(10)34924423
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/08/2026

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: 09/25/2026
• Device Model Number: H74939335150610
• Device Catalogue Number: H74939335150610
• Device Lot Number: 0034924423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 09/25/2024
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG