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

Model Number C408646

Device Problems Entrapment of Device (1212); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  Injury  

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.

Event Description

During the procedure, the stent was dislodged by the catheter.The stent had been placed and post pci run was performed.The stent was well apposed.On removal of the dragonfly catheter, it was observed that the stent had some misting around the distal portion.Dilatation was performed to dilate this portion of the stent again.There was no adverse patient consequence.The physician believed that the catheter had dislodged the stent as it was being removed.

Manufacturer Narrative

Additional information: corrected medical device problem code.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12306878
• MDR Text Key: 265994821
• Report Number: 3009600098-2021-00015
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7712266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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