MAUDE Adverse Event Report: ABBOTT VASCULAR 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 10/19/2021

Event Type  Injury  

Event Description

During the procedure, a dissection of the ostial circumflex artery occurred.The catheter was introduced into the distal circumflex artery lesion while another guidewire was in the left anterior descending artery.The first marker of the catheter passed the ostium of the circumflex artery, but the second marker went into the left anterior descending artery and the catheter became kinked.It was not possible to introduce the catheter at the desired location in the circumflex artery so the catheter was retrieved and reintroduced.When contrast was flushed, it was noticed that the ostial circumflex artery had been dissected by the catheter.It was not possible to advance the catheter and so no further imaging was performed.Fluoroscopy was used to diagnose the dissection and a drug-eluting stent was placed.The patient was stable.

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.The reported event of a positioning issue was able to be confirmed.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.Based on the information received and the condition of the returned device, the cause of the reported dissection remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591 ; 9519143996
• MDR Report Key: 12820251
• MDR Text Key: 280820097
• Report Number: 3009600098-2021-00022
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7943692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• 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