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

Model Number 1867

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: older than 18 years.(b)(6).Device evaluated by mfr: investigation completed on the returned device revealed blood inside the distal shaft.The hypotube, collar, distal shaft, and tip of the device were microscopically and visually inspected.Analysis revealed a partial separation at the collar, with collar damage (twisted material).Functional testing was attempted, but was unable to be performed due to the condition of the device.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 20feb2019.It was reported that severe resistance was met and the ancillary device was unable to be inserted.A guidezilla guide extension catheter was selected for use for a percutaneous coronary intervention procedure.When the physician attempted to advance to the lesion, severe resistance was felt around the collar portion of the device, and the balloon catheter was unable to be inserted successfully.The device position was manipulated, and insertion was attempted again, but the collar became deformed so the balloon catheter was removed without issue.The procedure was completed with the same device, but the guidewire was replaced.There were no patient complications reported.However, device analysis revealed that the collar was partially separated.

• 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: 8387237
• MDR Text Key: 137726640
• Report Number: 2134265-2019-01976
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0020510875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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