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

Model Number	1873
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred within the guide catheter.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The >80% stenosed target lesion was located in the mildly tortuous and moderately calcified coronary artery.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for treatment but failed to cross the lesion.During removal, the stent came off the balloon completely within the guidezilla ii guide catheter.Both the guidewire and guidezilla ii had to be pulled out to remove the dislodged stent.The procedure was completed with another of same device.There were no patient complications reported.

• Brand Name: GUIDEZILLA II
• 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: 16780175
• Report Number: 2124215-2023-17793
• Device Sequence Number: 6867869
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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: 10/27/2024
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0030441473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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 Sex: Unknown