MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Guidezilla? II; catheter, percutaneous

Model Number	H7493933515060
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter ruptured.A 6f guidezilla ii was selected for use.At the course of the procedure, prior to performing a coronary stent implantation, a catheter rupture was detected.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).

• 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 ; +1(612)875-7234
• MDR Report Key: 50531510
• Report Number: 2124215-2026-45829
• Device Sequence Number: 10163333
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)270423(10)36352549
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 0036352549
• 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: 08/02/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/23/2025
• 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: 79 YR
• Patient Sex: Male