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 Vascular Dissection (3160)

Event Date 01/07/2021

Event Type  Injury  

Event Description

Related manufacturing ref: 3009600098-2021-00006.During the procedure, a dissection occurred when two catheters became kinked and failed to cross the proximal right coronary artery lesion.The first catheter went in the vessel wall.The catheter was replaced, but the second catheter was caught in the damage caused by the first catheter.The catheter was replaced with a non-abbott device and the dissection was noticed.A stent was implanted to repair the vessel and complete the procedure with no patient consequences.

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.Functional testing revealed that the mini-rail measured 0.0155¿, which was within manufacturing specifications.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 kink.The cause of the kink is consistent with damage during use.Based on the condition of the device and the information received from the field, the exact cause of the reported dissection remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11337335
• MDR Text Key: 232167595
• Report Number: 3009600098-2021-00005
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7632804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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
• Treatment: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Patient Outcome(s): Required Intervention