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

Model Number	H7493933515060
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2026.It was reported that the device failed to cross the lesion due to calcification.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous left anterior descending artery.A guidezilla ii, 6f was selected for use.During introduction, the device failed to cross the lesion due to calcification.The procedure was completed with another of the same device.The procedure was completed and the patient was stable with no complications.However, analysis of the returned device revealed that the collar was detached.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.With all the available information, boston scientific concludes: device technical analysis: the device was returned for analysis.Inspection revealed that there was a collar weld plate separation.The tip was also damaged.Device history review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to patient condition, following a review of the reported event details, available information, and product record review.During product analysis it was observed a collar weld plate separation and the tip damaged, it is most likely the presence of anatomical calcification presented a constriction over the catheter and increase the friction when the device was advancing through the lesion reducing the mobility and generating the reported issues.Batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.

• 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: 50791825
• Report Number: 2124215-2026-49479
• Device Sequence Number: 13115718
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 0038583338
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male