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

Model Number 1867

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  malfunction  

Event Description

It was reported that the guidezilla was stuck in the lesion.The stenosed target lesion was located in the left anterior descending artery.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the guidezilla was scratched and became stuck in the lesion.The device was simply pulled out from the patient's body without any intervention and 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 was stuck in the lesion.The stenosed target lesion was located in the left anterior descending artery.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the guidezilla was scratched and became stuck in the lesion.The device was simply pulled out from the patient's body without any intervention and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, distal shaft, collar, and hypotube included microscopic and visual inspection.Inspection found no damage or defect to the returned device.

• Brand Name: GUIDEZILLA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10510673
• MDR Text Key: 209156745
• Report Number: 2134265-2020-12494
• 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
• Report Date: 10/19/2020

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: 07/08/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0024075595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 68