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

Model Number 1871

Device Problems Device Damaged Prior to Use (2284); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that device fracture occurred.A guidezilla ii was unpacked and the steel wire braid was exposed.The device was not used in the procedure.No patient complications were reported.

Event Description

It was reported that device fracture occurred.A guidezilla ii was unpacked and the steel wire braid was exposed.The device was not used in the procedure.No patient complications were reported.

Manufacturer Narrative

The device was returned for analysis.The device was visually and microscopically examined.There was blood present in the shaft of the device.There was partial collar and shaft detachment.There were numerous flat shaft segments to the device of which included the tip.Product analysis confirmed the reported event as the collar and shaft were partially detached.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15869234
• MDR Text Key: 307663037
• Report Number: 2124215-2022-49328
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: 08714729939450
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2023
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0027775289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG