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

Model Number	H7493933515060
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a collar detachment occurred.The 96% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 6f guidezilla guide extension catheter was selected for use.During the procedure while the device was inside the patient, it was noted that the connection port was fractured.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital.E1 initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a collar detachment occurred.The 96% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 6f guidezilla guide extension catheter was selected for use.During the procedure while the device was inside the patient, it was noted that the connection port was fractured.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that device was removed from the patient normally.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital.E1 initial reporter phone: (b)(6).Investigation results: 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.Investigation conclusion: this investigation has been assigned the conclusion code of adverse event related to procedure following a review of the reported event details, available information, and product record review.In this case the device was not returned for product analysis therefore limiting the identification of a most probable cause of the reported event, and batch record review concluded that no manufacturing deviations were identified during the manufacturing process, the issue could be related to an excessive force applied to the device during procedure, as well as operational factors such as handling/technique, causing the reported event.

• 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: 24458937
• Report Number: 2124215-2026-10827
• Device Sequence Number: 15954430
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)270729(10)37076068
• 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): 03/19/2026

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 Model Number: H7493933515060
• Device Catalogue Number: H7493933515060
• Device Lot Number: 0037076068
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 07/29/2025
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 49 KG