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

Model Number	1873
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidezilla damaged the stent.The target lesion was located in the severely tortuous artery.A 7f guidezilla ii was selected for use.A non-boston scientific drug eluting stent was advanced for treatment but was unable to cross the target lesion.The physician attempted to insert the stent through the guidezilla guide extension catheter, but there was resistance.When an attempt was made to remove the stent, there was strong resistance, and the stent was separated.The procedure was completed with a different device.There was no patient injury.
Additional Manufacturer Narrative
H6 device codes: corrected.The guidezilla ii 7f guide extension catheter was returned for analysis.The device was visually and microscopically examined.There was blood in the shaft of the device and the shaft was kinked at 6cm, 11cm, and 12.3cm distal from the collar.The drug eluting stent (des) was not returned for analysis.Given the severity of the kinked shaft, there was no need to functionally test the device with a des as the damage to the device could cause resistance and likely prevent the des from crossing or withdrawing through the guidezilla, which could lead to further device damage.Product analysis confirmed the reported events as the severity of the kink damage to the shaft of the device could cause resistance or damage to a concomitant device and likely prevent the device from advancement or removal.
Event or Problem Description
It was reported that the guidezilla damaged the stent.The target lesion was located in the severely tortuous artery.A 7f guidezilla ii was selected for use.A non-boston scientific drug eluting stent was advanced for treatment but was unable to cross the target lesion.The physician attempted to insert the stent through the guidezilla guide extension catheter, but there was resistance.When an attempt was made to remove the stent, there was strong resistance, and the stent was separated.The procedure was completed with a different device.There was no patient injury.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17438369
• Report Number: 2124215-2023-39925
• Device Sequence Number: 8913524
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/15/2023

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: 02/06/2025
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0031001744
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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