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

Model Number	1873
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that breakage occurred.The target lesion was located in the left circumflex artery.An 8f guidezilla ii guide extension catheter was selected for use.During the procedure, breakage was noted on the device when used and procedure was completed with a different device.No complications reported and patient was stable.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Inspection revealed numerous severe kinks to both the hypotube and shaft of the device.There was blood present in the shaft.Microscopic inspection revealed no further damage or irregularity.Product analysis could not confirm the reported event as there was no detachment or separation of the device.The device was returned intact, but the shaft and hypotube were found to be severely kinked.
Event or Problem Description
It was reported that breakage occurred.The target lesion was located in the left circumflex artery.An 8f guidezilla ii guide extension catheter was selected for use.During the procedure, breakage was noted on the device when used and procedure was completed with a different device.No complications reported and patient was stable.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18526219
• Report Number: 2124215-2023-75461
• Device Sequence Number: 20798075
• Product Code: DQY
• UDI-Device Identifier: 08714729939481
• UDI-Public: 08714729939481
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 03/15/2025
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0031245815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 68 KG