MAUDE Adverse Event Report: DRAGONFLY OPSTAR¿; DRAGONFLY OPSTAR IMAGING CATHETER

Model Number 1014652

Device Problems Entrapment of Device (1212); Material Frayed (1262)

Patient Problem Vascular Dissection (3160)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, a dissection occurred when the catheter was used at the rca lesion with tortuosity.While advancing the catheter into the lesion, it got stuck in pre-pci.A coronary artery dissection occurred when the device was removed with the guidewire.The tip of the catheter was frayed.Additional treatment was not necessary and ivus was used to continue and complete the procedure with no adverse consequences to the patient.

Manufacturer Narrative

One dragonfly opstar imaging catheter was received for evaluation.The results of the investigation concluded that the guidewire exit port had been torn in an outward direction toward the distal end; however, the tip of the catheter appeared non-anomalous and as expected with no fraying.Functional testing revealed that the catheter mini-rail measured 0.0155¿, which was within manufacturing specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Although the exact cause of the reported event and reported dissection issue remains unknown, the guidewire exit port damage is consistent with the reported event.The cause of the guidewire exit port damage is consistent with damage during use.

• Brand Name: DRAGONFLY OPSTAR¿
• Type of Device: DRAGONFLY OPSTAR IMAGING CATHETER
• MDR Report Key: 11181567
• MDR Text Key: 227474322
• Report Number: 3009600098-2021-00001
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K192019
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: 1014652
• Device Lot Number: 7588104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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): Required Intervention