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

Model Number 1871

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

Event Type  malfunction  

Event Description

It was reported that this device fractured the stent.The target lesion was located past the left main.A guidezilla ii guide extension catheter was used together with an unspecified stent.Upon removal, it was noted that the distal segment of the stent was stuck in the guidezilla.Subsequently, stent fragments were found as the guidezilla supposedly fractured/sheared the stent.There were no device fragments left inside the patient's body.The procedure was completed with another guide extension catheter.No complications reported and the patient is fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual examination revealed a kink to the hypotube 125.2cm from the handle.Microscopic inspection revealed damage to the tip.The device was x-ray and there were no abnormalities seen.The gudiezilla ii was functionally tested by inserting a guidewire with a rebel stented balloon through the device.No resistance was felt.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that this device fractured the stent.The target lesion was located past the left main.A guidezilla ii guide extension catheter was used together with an unspecified stent.Upon removal, it was noted that the distal segment of the stent was stuck in the guidezilla.Subsequently, stent fragments were found as the guidezilla supposedly fractured/sheared the stent.There were no device fragments left inside the patient's body.The procedure was completed with another guide extension catheter.No complications reported and the patient is fine.

• 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: 9093315
• MDR Text Key: 159325302
• Report Number: 2134265-2019-11335
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

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
• Device Operator: Health Professional
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0023656546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1