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

Model Number	1867
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device fracture occurred.The target lesion was in the distal left anterior descending artery.A guidezilla 145 guide extension catheter was selected for use.During the preparation, it was noted that the catheter of the guidezilla and the steel beam of the guidewire fractured during removal, and the use was finally abandoned.No patient complications reported.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that device fracture occurred.The target lesion was in the distal left anterior descending artery.A guidezilla 145 guide extension catheter was selected for use.During the preparation, it was noted that the catheter of the guidezilla and the steel beam of the guidewire fractured during removal, and the use was finally abandoned.No patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter address (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.There was no sign of blood in the shaft of the device.There was partial shaft detachment and a shaft kink at the most distal end of the collar.Inspection of the remainder of the device presented no damage or irregularities.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16246447
• Report Number: 2124215-2023-01940
• Device Sequence Number: 6552665
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 12/18/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026544446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG