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

Model Number 1871

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a guidezilla ii guide extension catheter.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual inspection revealed a kink to the hypotube 32.4cm from the handle.The tip is damaged so that it is no longer circular.Microscopic inspection revealed no additional damages.The device was x-rayed and there does not appear to be any abnormalities with the inside diameter of the shaft.The device was functionally tested by inserting a 0.014 guidewire and balloon through the inside diameter of the shaft.No resistance was felt.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that a device irregularity led to balloons tearing.The 90% stenosed target lesion was located on the moderately tortuous and severely calcified proximal and mid left anterior descending artery.A 6f guidezilla ii was selected for use.During the procedure, a guidezilla device was advanced to the lesion area of proximal lad.Two non-bsc balloons were advanced through the guidezilla ii to the lesion and both ruptured at 2-3 atmospheres (atm).When the balloons were checked outside the patient's body, they were observed to have longitudinal tears.It was suspected that there was a damage or irregularity in the guide segment / distal shaft of the device that make the balloons tear longitudinally.The devices were completely and simply pulled out from the patient's body.The procedure was completed with the original guidezilla ii device.There were no patient complications reported.Patient was in good condition post procedure.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8920939
• MDR Text Key: 155218074
• Report Number: 2134265-2019-10107
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: 08714729939450
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2021
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0023800291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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