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

Model Number 1873

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the guidezilla ii guide extension catheter.The shaft, collar, and tip were microscopically and visually examined.Blood was present on the outside and inside of the device.Inspection of the device revealed that the hypotube was kinked at the collar and there were numerous kinks throughout the shaft.The collar shaft was twisted and partially detached with the metal portion of the collar damaged and pulled away from the shaft due to the shaft material being twisted underneath it.The damage to the collar is consistent with the device being torqued/twisted in one direction by the user during use.

Event Description

Reportable based on device analysis completed on 01jul2021.It was reported that there was a difficulty reaching the lesion and the catheter was damaged.The target lesion was located in the right coronary vessel.A guidezilla ii was selected for use.During the procedure, it was noted that there was a difficulty reaching out the lesion even with the assistance of the guidezilla ii.Damaged was noted on the junction between the distal end of the delivery shaft and the cutaneous canal.The guidezilla ii was replaced and the procedure was completed.There were no complications reported.However, device analysis revealed that the shaft was partially detached.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12137772
• MDR Text Key: 260576463
• Report Number: 2134265-2021-08733
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0026386508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1