MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408646

Device Problem Positioning Problem (3009)

Patient Problem Vascular Dissection (3160)

Event Date 07/31/2019

Event Type  Injury  

Event Description

Manufacturing related ref: 3009600098-2019-00020.During the procedure, a dissection occurred in the left main.The catheter attempted to advance to the lad but was experiencing buckling proximal to the guidewire exit port.A second catheter was attempted to be used but the issue persisted.A dissection occurred in the left main and a flap of tissue was seen on an angiogram.The lad was not able to be treated because of the dissection.A stent was replaced and the issue was resolved.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8921284
• MDR Text Key: 155221602
• Report Number: 3009600098-2019-00019
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2021
• Device Model Number: C408646
• Device Lot Number: 7008740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR