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

Model Number 1867

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, distal shaft, collar, hypotube and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation of the collar/shaft, with numerous kinks in the distal shaft and numerous kinks in the hypotube.Inspection of the returned device found no other damage or defect with the device.The guidezilla could not be tested for interaction with a 6f guide catheter due to the separation of the shaft from the collar.However, review of the product specification indicates the guidezilla is compatible with a guide catheter with an inner diameter greater than or equal to.067/6f guide catheter.The reported information indicates the guidezilla was used with a 6f guide catheter; therefore, there is no indication of a compatibility issue.The outer diameter of the distal shaft was measured with a calibrated micrometer and met specification.The damaged portion of the shaft measured exceeded the specification.

Event Description

Reportable based on device analysis completed on 18jun2020.It was reported that the device could not enter the guide catheter.The target lesion was located in the left coronary artery.A guidezilla guide extension catheter was selected for use.During procedure, it was noted that the device could not enter the non-bsc 6fr guide catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.However, device analysis revealed a complete separation of the collar/shaft.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10224373
• MDR Text Key: 197330520
• Report Number: 2134265-2020-08847
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0024483171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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: 69 YR
• Patient Weight: 56