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

Model Number	H7493933515060
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 27mar2026.It was reported that the guide extension catheter was kinked.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 6f guidezilla ii guide extension catheter was selected for use.During the procedure, guide extension catheter was kinked.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that a collar weld plate separation occurred.
Additional Manufacturer Narrative
Device analysis findings: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection revealed that there was a collar weld plate separation.No other issues were identified during the product analysis.Device/media analysis: during product analysis, the returned device presented no damage that could be related to the reported event.Therefore, the reported complaint is not confirmed.Additionally, the collar weld plate separation found during the analysis could not have contributed to reported issue.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 an investigation conclusion code of no problem detected following a review of the returned device, reported event details, available information, and product record review.In this case, the device performed as intended during the analysis, and no damage was found that could have contributed to the reported allegation.Also, the batch record review concluded that no manufacturing deviations were identified during the manufacturing process that could have contributed to the complaint.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 collar weld plate separation.(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 ; 7634941632
• MDR Report Key: 24772818
• Report Number: 2124215-2026-18302
• Device Sequence Number: 18614222
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)270729(10)37076013
• 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
• Report Date (Section B): 04/02/2026

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: 0037076013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG