MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II GUIDE EXTENSION CATHETER; CATHETER, PERCUTANEOUS

Model Number H7493933515080

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the returned product consisted of a bloody 8f guidezilla ii guide extension catheter.The device was put in a warm waterbath with sonic cleaning for 5 minutes.The hypotube, collar, distal shaft and tip were microscopically and tactile inspected.Inspection revealed a kink in the distal shaft located 7.5 cm from the collar, with damage (chatter lines) to the hypotube/collar.The collar was measured with a calibrated pin gage and the measurement met the product specification.The chatter lines were likely caused by the burr of the rota link device rotating/oscillating outside of the guidezilla/inside the guide catheter, thus contributing to the resistance when trying to enter the collar.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Reportable based on device analysis completed on 26 february 2018.It was reported that there was difficulty advancing another device through this device.A 8f guidezilla¿ ii guide extension catheter was selected to be used for a percutaneous coronary intervention procedure.The physician attempted to use this device together with 1.5mm boston scientific rota burr.However, the burr was unable to advance through this device; it was only able to be slightly inserted into the collar section.The physician attempted to pass the burr through while using the boston scientific- rotablator device- "dynaglide mode," but it was still unable to pass.Therefore, the burr and guidezilla were removed from the patient.The procedure was successfully completed by using the same 1.5mm burr, that failed to pass through the first guidezilla, along with another guidezilla device.No patient complications were reported.However, device analysis showed chatter lines on the hypotube/collar area of the guidezilla.

• Brand Name: GUIDEZILLA¿ II GUIDE EXTENSION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7356926
• MDR Text Key: 103035202
• Report Number: 2134265-2018-02272
• Device Sequence Number: 1
• Product Code: DQY
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2019
• Device Model Number: H7493933515080
• Device Lot Number: 20598944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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