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 01/14/2019

Event Type  malfunction  

Event Description

It was reported that the guidezilla collar damaged a stent.Vascular access was obtained via the radial artery.The target lesion was located in the left anterior descending artery (lad).A 6f guidezilla ii guide extension catheter was selected for use.During the procedure, there was resistance met at the collar of the guidezilla after a non-bsc stent was placed.Furthermore, the stent could not be pulled.Also, it was noted that the stent was squished up and damaged during removal on the collar of the guidezilla.The procedure was completed with this device.No patient complications were reported and patient's status was fine.

Event Description

It was reported that the guidezilla collar damaged a stent.Vascular access was obtained via the radial artery.The target lesion was located in the left anterior descending artery (lad).A 6f guidezilla ii guide extension catheter was selected for use.During the procedure, there was resistance met at the collar of the guidezilla after a non-bsc stent was placed.Furthermore, the stent could not be pulled.Also, it was noted that the stent was squished up and damaged during removal on the collar of the guidezilla.The procedure was completed with this device.No patient complications were reported and patient's status was fine.It was further reported that the stent was deformed upon advancing through the collar portion of the guidezilla.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The tip, distal shaft, collar and hypotube were microscopically and visually inspected.Inspection observed that the collar flared out and distal shaft was flattened at 27mm from the tip of the device.Inspection of the remaining device found no other damage or irregularities.The stent used in the procedure was not returned for functional testing, thus, a lab supplied 4.0 stented balloon catheter was used to functional test the guidezilla.The stented catheter was loaded into the guidezilla collar, and advanced through the distal shaft.The stent advanced without issue until the area of shaft damage, and it took a little bit of force before the stent exited out from the guidezilla tip.

• 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: 8312005
• MDR Text Key: 135225570
• Report Number: 2134265-2019-00804
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: 08714729939450
• 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: 03/08/2019

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 Expiration Date: 10/04/2020
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0022889664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1