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

Model Number 1871

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

It was reported that the stent became damaged during use with the guidezilla ii.A 2.50x16 synergy ii drug eluting stent and a 6f guidezilla ii guide extension catheter were selected for use.During the procedure, a guidewire was crossed and pre-dilation was performed at the chronic total occlusion lesion in the right coronary artery.Then, the physician tried to cross the synergy stent; however, it was noted that the device failed to cross.Consequently, the physician attempted to use the synergy stent in combination with the 6f guidezilla ii; however, it was still unable to cross.Furthermore, when the devices were removed from the patient's body to replace with a non bsc guide catheter, it was noted that the stent was lifted.The procedure was completed with another of the same stent and a non bsc catheter.There were no patient complications reported.

• 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: 9221234
• MDR Text Key: 166425119
• Report Number: 2134265-2019-12772
• 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: 10/22/2019

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: 0024137845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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