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

Model Number 1014652

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 01/22/2021

Event Type  Injury  

Event Description

During the procedure, when the catheter was inserted into the left circumflex artery lesion, air entered and caused peripheral embolization and vital changes in the patient.No pullback had been performed with the catheter.There were no patient symptoms initially.The peripheral embolization was diagnosed by cine image.After the peripheral embolization, pressure decrease and st elevation occurred, and the patient experienced chest pain.A stenosis-penetration catheter was used for suction and nicorandil and nitroprusside were administered for treating the embolization.After that, stenting was performed using intravascular ultrasound as a guide, and the procedure was completed.The patient is in stable condition postoperatively.

Manufacturer Narrative

One dragonfly opstar imaging catheter was received for evaluation.Functional testing was not possible due to the presence of dried contrast within the catheter sheath; however, dimensional inspection revealed the purge hole diameter met the specifications.There were no anomalies, ruptures, or damages noted to the returned catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the condition of the returned device and the information received, the cause of the reported leak and embolism remains unknown.

• Brand Name: DRAGONFLY OPSTAR¿
• Type of Device: DRAGONFLY OPSTAR IMAGING CATHETER
• MDR Report Key: 11313456
• MDR Text Key: 231351100
• Report Number: 3009600098-2021-00007
• 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,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: 1014652
• Device Lot Number: 7657565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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