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

Model Number H7493933515060

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).Returned product consisted of a guidezilla guide extension catheter.The device was bloody.The hypotube, collar, distal shaft and tip was microscopically and tactile inspected.Inspection revealed numerous kinks in the hypotube, a partial separation at the collar, a kink in the distal shaft located at 18cm and 19.5 cm from the tip, and tip damage (ptfe separating/stretched).Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 21dec2017.It was reported that the device was unable to cross the lesion, the device damaged a stent and the device was deformed.A guidezilla¿ ii guide extension catheter was selected for a percutaneous coronary intervention (pci) procedure in the left circumflex coronary artery (lcx) proximal.During the procedure, the guidezilla was unable to cross the lesion but was placed in the left main trunk (lmt).A non-bsc stent was advanced and was unable to cross the lesion.It was noted that the non bsc stent was lifted up.There were a few deformations observed at the entrance part of the guidezilla so the deice was removed and the procedure was completed with a different device.There were no patient complications reported.However, device analysis revealed a partial separation at the collar.

• 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: 7200477
• MDR Text Key: 97896269
• Report Number: 2134265-2017-13150
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2019
• Device Model Number: H7493933515060
• Device Lot Number: 20802030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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