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

Model Number 1873

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated based on aware date of (b)(6) 2020.

Event Description

It was reported that collar separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the device became unraveled at the collar and was unable to be used.The stent being used was dislodged.A second guidezilla device was used and the procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

B3: date of event: estimated based on aware date of (b)(6) 2020.Device evaluated by manufacturer.Returned product consisted of a 6f long 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 30.5cm from the tip of the device.Inspection of the rest of the device found no other damage or defect.The device reported to be used with the guidezilla was not returned for analysis, so a lab supplied stented balloon catheter was used for testing with the guidezilla.The stented catheter was inserted into the collar of the guidezilla and advanced through the distal shaft and out through the tip.There was no resistance advancing and the stent remained in its original, mounted position.The reported collar/shaft separation and the stent dislodgement were not confirmed.

Event Description

It was reported that collar separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the device became unraveled at the collar and was unable to be used.The stent being used was dislodged.A second guidezilla device was used and the procedure was completed successfully.No patient complications were reported.

Event Description

It was reported that collar separation occurred.A 6f guidezilla ii was selected for use.During the procedure, the device became unraveled at the collar and was unable to be used.The stent being used was dislodged.A second guidezilla device was used and the procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer.Returned product consisted of a 6f long 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 30.5cm from the tip of the device.Inspection of the rest of the device found no other damage or defect.The device reported to be used with the guidezilla was not returned for analysis, so a lab supplied stented balloon catheter was used for testing with the guidezilla.The stented catheter was inserted into the collar of the guidezilla and advanced through the distal shaft and out through the tip.There was no resistance advancing and the stent remained in its original, mounted position.The reported collar/shaft separation and the stent dislodgement were not confirmed.

• 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: 9963814
• MDR Text Key: 187871652
• Report Number: 2134265-2020-05078
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• 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,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0024663539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1