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

Model Number C408646

Device Problems Difficult to Advance (2920); Material Too Soft/Flexible (4007)

Patient Problems Cardiac Arrest (1762); Vascular Dissection (3160)

Event Date 05/10/2023

Event Type  Death  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

A user facility biomedical technician (biomed) contacted fresenius technical support (ts) to report that a dry acid 132 gallon mixer was not filling in dissolution or rinse mode.During troubleshooting the biomed discovered that the fill valve was melted, however the cable was still intact.The biomed replaced the fill valve which did not immediately resolve the issue.The biomed then borrowed a control board from a different mixer and replaced that, and this resolved the problem.Upon follow-up, it was confirmed that the mixer was experiencing filling issues and subsequent thermal damage was found on the fill valve.The biomed stated the fill valve looked burnt and melted, and a burning smell was noticed.The biomed also noticed some smoke coming from the mixer.They confirmed resolving the reported issue by replacing both the fill valve and the control board.There was no visible damage on the control board or any other components.The biomed stated the mixer is in a room with high humidity and wondered if this could have contributed to the reported issue.Despite reports of smoke, the smoke detector did not go off.It was confirmed that no treatments were impacted due to the reported events; there was no patient involvement.Both replaced parts were reported to be available for manufacturer evaluation.No photos were provided for review.

Event Description

N/a.

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 indication of a lot specific product quality issue.Based on the information provided, the cause for the reported difficulty to advance and prolapse was unable to be confirmed.It is likely that the patient anatomical condition(s) or the use technique(s) employed caused or contributed to the reported difficulties; however, this could not be confirmed.The cause for the reported abnormal heart arrhythmias (cardiac arrest) and vascular dissection, and the relationship to the product, if any, could not be determined.The cause for the reported death, and the relationship to the product, if any, could not be determined.The reported patient effects of abnormal heart arrhythmias (cardiac arrest), vascular dissection, and death are listed in the dragonfly optis instruction for use as known complications that may occur as a consequence of intravascular imaging and catheterization procedures.Further medical review was unable to determine a cause for the reported patient issues due to the lack of information provided and the absence of any cine images to review; therefore, the dragonfly optis catheter cannot be directly attributed to the reported death but may have been an indirect cause of death for this patient.It may also be possible that excessive force was applied during the attempt to cross the catheter, which can also cause vascular dissection resulting in cardiac arrest; however, this could not be confirmed.The unexpected medical intervention (cardiopulmonary resuscitation and vascular recanalization), extracorporeal membrane oxygenation (ecmo), intubation, and prolonged hospitalization were related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 17025274
• MDR Text Key: 316191503
• Report Number: 2024168-2023-05642
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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: 8825732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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): Death
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 84 KG