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

Model Number 1867

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 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a guidezilla guide extension catheter.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Inspection revealed a partial separation at the collar and tip damage (misshapen).The damage to the tip is likely attributed to being used in a procedure and with a guide wire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 13-dec-2018.It was reported that the guidezilla was broken proximal to the hypotube transition zone near the hub.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the catheter was broken proximal to the hypotube transition zone 0.5 cm from the hub.Furthermore, two non bsc stents broke because of the guidezilla.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, device analysis revealed a partial separation at the collar.

• Brand Name: GUIDEZILLA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8215136
• MDR Text Key: 132046491
• Report Number: 2134265-2018-64702
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0022239931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• 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: 43 YR