MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number C408646

Device Problem Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a lesion in the mid left circumflex (lcx).Optical coherence tomography (oct) guided percutaneous coronary intervention (pci) was performed with the dragonfly catheter.Pci was successful, however after post pci oct the dragonfly catheter was caught on the flexible part of the run through guide wire and was unable to pull back into the guide catheter and out of the body.After more aggressive pulling of the dragonfly catheter in an attempt to remove from the patient, the guide catheter was consequently deep seated into the left main coronary artery.After finally successfully removing the oct catheter from the patient, further angiography indicated a dissection of the left main coronary artery.The dissection did not appear to be severe therefore the patient was taken to the post operative evaluation unit.No treatment was performed for the dissection.Per the physician the dragonfly catheter may have contributed to the dissection.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents and/or complaints reported from this lot.The reported patient effect of vascular dissection is listed in the dragonfly optis instruction for use as a known complication that may occur as a consequence of intravascular imaging.In this case, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information provided, the reported difficulty appears to be due to circumstances of the procedure.It is likely that the reported difficulty removing was due to the dragonfly optis catheter being caught on the flexible part of the run through guide wire causing difficulty removing.A definitive cause for the dissection resulting in serious injury and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 - device available for evaluation updated from yes to no.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16466792
• MDR Text Key: 310501287
• Report Number: 2024168-2023-02115
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8802856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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): Other
• Patient Sex: Male