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

Model Number 1867

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  malfunction  

Event Description

It was reported that the guidezilla damaged another device.A guidezilla guide extension catheter was selected for use with a stent.During the procedure, it was noted that the stent was damaged in the guidezilla.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Event Description

It was reported that the guidezilla damaged another device.A guidezilla guide extension catheter was selected for use with a stent.During the procedure, it was noted that the stent was damaged in the guidezilla.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.It was further reported that the target lesion was located in the right coronary artery and that the stent was damaged in the guidezilla during advancing.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a guidezilla guide extension catheter.The device was bloody.Analysis of the tip, distal shaft, collar and hypotube included microscopic and visual inspection.Inspection revealed a kink in the distal shaft located 187.5cm from the tip of the device.The tip and collar of the device were measured with a calibrated plug gage and found to meet specification.The stent that was used in the procedure was not returned with the guidezilla.A 4.0 stented balloon catheter was used to functionally test the device.The stent was loaded into the guidezilla collar and advanced.The stent advanced smoothly and exited out of the tip without issue.Analysis of the rest of the device found no other damage or defect.

Event Description

It was reported that the guidezilla damaged another device.A guidezilla guide extension catheter was selected for use with a stent.During the procedure, it was noted that the stent was damaged in the guidezilla.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.It was further reported that the target lesion was located in the right coronary artery and that the stent was damaged in the guidezilla during advancing.

• Brand Name: GUIDEZILLA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10088607
• MDR Text Key: 192043562
• Report Number: 2134265-2020-06923
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (y/n): N
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0024075597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 72