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

Model Number	1873
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.An 8f guidezilla ii guide extension catheter was selected for use inside an 8f mach 1 guide catheter.The procedure was 3 hour chronic total occlusion (cto) procedure.The target lesion was located in the middle left anterior descending cto artery.Upon successful crossing of cto and intervention, the guidezilla ii catheter was removed without resistance.During withdrawal, only the hypotube was removed.It was observed that the guidezilla ii fractured at the neck within the mach 1 guide catheter.The physician secured the fractured distal end of the guidezilla ii and removed the mach 1 and guidezilla ii successfully together.The procedure was completed with the original device used.No complications were reported and patient condition was fine.The patient was discharged the following day.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a guidezilla ii guide extension catheter with an introducer sheath.The hypotube and collar were microscopically and visually inspected.Visual inspection revealed that the distal shaft was separated at the collar.The distal shaft did not return for product analysis.The collar appears to be slightly flattened.There were kinks on the hypotube at 45cm and 73cm from the handle.Microscopic inspection revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the distal shaft at the collar was separated.
Event or Problem Description
It was reported that a device fracture occurred.An 8f guidezilla ii guide extension catheter was selected for use inside an 8f mach 1 guide catheter.The procedure was 3 hour chronic total occlusion (cto) procedure.The target lesion was located in the middle left anterior descending cto artery.Upon successful crossing of cto and intervention, the guidezilla ii catheter was removed without resistance.During withdrawal, only the hypotube was removed.It was observed that the guidezilla ii fractured at the neck within the mach 1 guide catheter.The physician secured the fractured distal end of the guidezilla ii and removed the mach 1 and guidezilla ii successfully together.The procedure was completed with the original device used.No complications were reported and patient condition was fine.The patient was discharged the following day.

• Brand Name: GUIDEZILLA II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9136321
• Report Number: 2134265-2019-11755
• Device Sequence Number: 16791578
• Product Code: DQY
• UDI-Device Identifier: 08714729939481
• UDI-Public: 08714729939481
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0021441618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 8F MACH 1; GUIDE CATHETER: 8F MACH 1