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

Model Number 1871

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)

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

Event Date 08/13/2021

Event Type  malfunction  

Event Description

It was reported that a guidewire tip detached during removal through the guidezilla ii.A 6f guidezilla ii guide extension catheter was selected for use.During the procedure, when the guidezilla ii was inside the guide catheter, the physician advanced a non boston scientific guidewire and noticed that the guidewire snagged.When the guidewire was removed, it was noted that the tip of the guidewire was detached.Consequently, the physician removed the guidezilla ii and noticed that the guidewire tip got stuck at the collar part of the device.The procedure was completed with another of same non boston scientific guidewire and guide catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The shaft, collar, and tip were microscopically examined.There were numerous kinks in the hypotube and numerous severe kinks throughout the shaft of the device.The id (inner diameter) of the collar was measured using a calibrated pin gauge and the id was.057'', which is within specification.The wire used in the procedure with the guidezilla ii complaint device was returned for analysis, so it was used for functional testing.The wire was received separate from the guidezilla device.The wire was able to be inserted into collar and advanced through the shaft of the device but met resistance at the severe kinks.The photos in the complaint record were reviewed.The photos show the tip of the guidewire all tangled up at the collar of the guidezilla ii device.There is no damage to the guidezilla device, used blood present inside and outside of the device.The returned devices did not match the photo, as the wire was received separately and the spring tip that was tangled, was not returned with the guidezilla ii device.The portion of the guidezilla ii device in the photo matches the returned device, as there was no damage.Product analysis confirmed the reported event, as the shaft was severely kinked making the guidewire to meet resistance and damaging the tip.

Event Description

It was reported that a wire became separated at the collar part of the guidezilla.A 6f guidezilla ii guide extension catheter was selected for use.During the procedure, when the guidezilla ii was inside the guide catheter, the physician advanced a non boston scientific guidewire and noticed that the wire snagged.When the wire was removed, it was noted that the tip went missing.Consequently, the physician removed the guidezilla ii and noticed that the wire tip got stuck at the collar part of the device.The procedure was completed with another of same non boston scientific guidewire and guide catheter.No patient complications were reported.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12381324
• MDR Text Key: 268654895
• Report Number: 2134265-2021-10895
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0027444285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1