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

Model Number 1873

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)

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

Event Date 08/19/2021

Event Type  malfunction  

Event Description

It was reported that peeling occurred on the guidezilla ii.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A guidezilla ii guide extension catheter was selected for use.During the procedure, the nc emerge 3x12 balloon was unable to cross inside the guidezilla ii guide extension catheter.The nc emerge 3x12 balloon was removed.The port opening of the guidezilla ii was observed to be damaged.The guidezilla ii was checked and peeling was observed.The devices were completely removed from the patient's body and the procedure was completed with the same balloon and another of the same guidezilla ii.No patient complications were reported.

Event Description

It was reported that the guidezilla had coating issues.The 99% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A guidezilla ii guide extension catheter was selected for use.During the procedure, the nc emerge 3x12 balloon was unable to cross inside the guidezilla ii guide extension catheter.The nc emerge 3x12 balloon was removed.The port opening of the guidezilla ii was observed to be damaged.The guidezilla ii was checked and peeling was observed.The devices were completely removed from the patient's body and the procedure was completed with the same balloon and another of the same guidezilla ii.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.Returned product consisted of a guidezilla ii 7f guide extension catheter.The hypotube, shaft, collar, and tip were microscopically examined.There was no damage to the collar or to any part of the guidezilla device.The id (inner diameter) of the collar was measured using a calibrated pin gauge and the id was within specification.The balloon catheter used in the procedure with the guidezilla ii complaint device was not returned for analysis, so a test sds (stent delivery system) was used for functional testing.The device was able to be inserted into collar and advanced through the shaft and out of the tip with no difficulties.Product analysis did not confirm the reported event, as there was no damage to the collar and the test sds was able to be advanced with no issues.

• 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: 12446965
• MDR Text Key: 270545474
• Report Number: 2134265-2021-11451
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0026952083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1