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

Model Number 1867

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Heart Failure (2206); Vascular Dissection (3160)

Event Date 09/28/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced vessel dissection and other complications.The target lesion was located in the right coronary artery (rca).A guidezilla guide extension catheter was selected for use.At 9:30 a.M.Of the procedure, the case started out as a chronic total occlusion (cto) in the rca with intentions of cannulating a septal artery off of the left anterior descending artery (lad) for a retrograde approach percutaneous coronary intervention (pci).There was mild disease in the lad.After more than three hours of repeat cannulation of the lad and subsequent septal arteries, the physician was able to reach the distal cap of the rca cto with added support from the guidezilla extension catheter.Then, attempts were made to pass through the cto, at which time the patient went into ventricular tachycardia and then ventricular fibrillation.Consequently, the patient was defibrillated multiple times and was eventually put on an impella left ventricular assist device.After patient was somewhat stable, an injection of the lad was performed and the physician noticed that there was a clot or dissection present in the lad.A grade f dissection was confirmed in the proximal lad to apex.Then, five synergy stents were selected to cover the dissection in the lad.The patient is currently still on the impella device and in the icu and the case concluded around 17:30.The patient had right ventricular failure from all the shocks and was transferred for extracorporeal membrane oxygenation (ecmo).The patient did well over the weekend and was weaned from ecmo.The patient was doing good.

• 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: 7984762
• MDR Text Key: 124333847
• Report Number: 2134265-2018-62085
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR