MAUDE Adverse Event Report: ST. JUDE MEDICAL DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; DF OPTIS KIT OUS

Model Number C408646

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

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/28/2018

Event Type  Injury  

Event Description

A dragonfly optis catheter was used for pci on three diseased vessels - lcx, lad, and rca lesions.The lesion in the lcx was successfully treated.The proximal lad had no tortuosity, calcification, or stenosis.The patient experienced ventricular fibrillation when the catheter was inserted into the proximal lad lesion and contrast was used.Electrical defibrillation was done and the patient stabilized.Another oct attempt was performed and when the contrast was used, the patient experienced ventricular fibrillation again.Electrical defibrillation was used again and the patient stabilized.A non-abbott device was used to complete the treatment.The rca was rescheduled to be treated two days later as elective staged pci and was successfully treated with non-abbott devices.

Manufacturer Narrative

An event of ventricular fibrillation was reported.The results of the investigation concluded that no visual anomalies to the returned catheter were noted.However, dried contrast inside the catheter prevented flushing of the catheter to verify the reported event.Dimensional inspection revealed that the outer diameter of the window tube and shaft is consistent with the specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported event remains unknown.The dragonfly optis instructions for use states the following complications may occur as a consequence of intravascular imaging: coronary artery spasm, unstable angina, allergic reaction to the contrast media, arterial dissection, injury or perforation, thrombus formation, abrupt closure, or total occlusion, abnormal heart arrhythmias, embolism, acute myocardial infarction, death.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: DF OPTIS KIT OUS
• Manufacturer (Section D): ST. JUDE MEDICAL; 4 robbins drive; westford MA 01886
• MDR Report Key: 7422984
• MDR Text Key: 105237381
• Report Number: 3009600098-2018-00007
• Device Sequence Number: 1
• Product Code: ORD
• Combination Product (y/n): N
• PMA/PMN Number: K141453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 6206691
• Other Device ID Number: 00183739000654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTRICAL DEFIBRILLATION
• Patient Outcome(s): Hospitalization; Other