MAUDE Adverse Event Report: DRAGONFLY¿ OPTIS¿ CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408641

Device Problem Difficult to Insert (1316)

Patient Problem Vascular Dissection (3160)

Event Date 07/25/2021

Event Type  Injury  

Event Description

During the procedure, there was difficulty when attempting to cross the lesion and the lad was dissected.Ultrasound was used to used to diagnose the dissection.A stent was placed to treat the dissection and the patient was stable.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that no visual anomalies were noted that could be attributed to the reported positioning issue.The 0.014¿ guidewire was able to be inserted through the tip of the catheter and out the guidewire exit port with no anomalies or resistance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported positioning issue and dissection remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12355468
• MDR Text Key: 267734082
• Report Number: 3009600098-2021-00016
• Device Sequence Number: 1
• Product Code: DQO
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: C408641
• Device Lot Number: 7846103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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