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

Model Number C408646

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem Cardiac Perforation (2513)

Event Date 03/11/2021

Event Type  Injury  

Event Description

The device became kinked in the left circumflex artery and was unable to cross the lesion, which resulted in a perforation.The patient developed chest pain and the catheter was removed.A small pericardial effusion occurred that did not require a pericardiocentesis.The perforation was treated with a balloon tamponade followed by a covered stent and analgesia was required to treat the pain.The patient later experienced hospital acquired pneumonia and atrial fibrillation with rapid ventricular rate, so the patient remained in the cardiac care unit.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that the catheter had been kinked between the lens and the guidewire exit port.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported positioning issue is consistent with the kinks.The cause of the kinks is consistent with damage during use.The reported cause of the perforation remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11637848
• MDR Text Key: 244605743
• Report Number: 3009600098-2021-00012
• 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,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 6906068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• 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