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

Model Number 1873

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address 1-(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that there was blood in the shaft of the device and the collar weld plate was separated.Due to damage present, further functional testing was not performed.Microscopic inspection revealed no further damage or irregularities.Product analysis confirmed the reported events as the collar weld plate was separated.The damage present would prevent further device advancement and further functional testing was not performed due to this damage.

Event Description

Reportable based on device analysis completed on 26feb2024.It was reported that the shaft was abnormal, and device could not cross the guide catheter.The 96% stenosed target lesion was located in the left anterior descending artery.A 6f guidezilla ii guide extension catheter was selected for use.During the procedure, it was noted that the red connection of the delivery shaft was abnormal.It could not cross and enter the guiding catheter.The procedure was completed with another of the same device.No complications reported and patient was stable.However, device analysis revealed that collar weld plate was separated.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18932609
• MDR Text Key: 338089579
• Report Number: 2124215-2024-15481
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0031625575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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
• Treatment: GUIDE CATHETER- MEDTRONIC EBU
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG