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

Model Number C408646

Device Problem Failure to Advance (2524)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported the patient was presented with non-st-elevation myocardial infarction (nstemi).The first dragonfly imaging catheter (8990559) was connected and after positioning the in the circumflex (cx) the image during live view showed multiple bright rings.A new dragonfly (8957539) was connected, and pullback was performed in the cx, there was no calcification or tortuosity.A second pullback of the left anterior descending (lad) artery was performed to visualize a stent that was placed in 2020.Some thrombus was visible at the proximal segment, due to malapposition.The decision was made to not treat but instead to give medication.A third pullback was done at the diagonal.The stent of the lad was crossed to enter the diagonal.There was already some resistance.The cx was successfully treated with a des.The user wanted to visualize the result; however, the dragonfly catheter could not be advanced into the cx.Resistance was felt when the dragonfly came out of the guiding catheter.They tried for a long period, but the catheter would not advance, due to a lot of resistance.Due to this issue, a thrombus appeared in the left main that embolized to the distal cx.The result was a closed cx, in which the patient had an inferior wall myocardial infarction.Thrombosuction was performed, balloon dilatation and eptifibatide infusion was started.The patient was sent back to the referral hospital with almost normalized electrocardiogram (ecg).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 identified no other complaints reported from this lot.Potential causes which could contribute to difficulty advancing or failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, damage to the dragonfly or accessory device support.The reported patient effects of thrombus and myocardial infarction are listed in the instruction for use (complications section) as known adverse effects of intravascular imaging.In this case, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The investigation was unable to determine a cause for the reported failure to advance.It may be possible that adverse patient anatomical morphology, in conjunction with the malapposed stent, damaged the device and affected maneuverability.Furthermore, while advancing against resistance, the device may have been further damaged resulting in the failure to advance.However, this could not be confirmed.Additionally, a cause for the reported patient effects of thrombosis/thrombus, myocardial infarction, medication required, unexpected medical intervention, hospitalization or prolonged hospitalization 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.

• 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: 17100637
• MDR Text Key: 317028118
• Report Number: 2024168-2023-06122
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K141769
• 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
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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: 8957539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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): Disability; Required Intervention; Hospitalization