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

Model Number C408646

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After pullback was performed during an optical coherence tomography (oct) procedure, the catheter was found to be leaking.While the device was inside the patient's anatomy, a contrast leak was noticed from a hole where the small tube connected to the catheter.It was difficult to get contrast out of the distal tip due to the leak.A large syringe was used but the issue persisted.The procedure was completed without oct with no adverse consequences to the patient.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that a leak was noted at the proximal seal of the x-ring retainer.Further investigation revealed that the seal was damaged, resulting in a deformation on the seal, from which a leak was noted.It was also noted that the syringe was exchanged for a larger syringe during the procedure.The ifu instructs the user to ¿use a 3 ml syringe and purge until 3-5 drops exit from the purge exit.Do not remove this syringe from the catheter purge port.¿ additionally, the catheter goes through a 200% inspection process for leaks and damages, ensuring the defect and subsequent leak were not present at the time of manufacturing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided, a conclusive cause for the reported difficulties could not be determined.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11174778
• MDR Text Key: 227050870
• Report Number: 3009600098-2021-00003
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7695725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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