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 High Blood Pressure/ Hypertension (1908); Vascular Dissection (3160)

Event Date 06/12/2023

Event Type  Injury  

Event Description

It was reported that it was hard to deliver the dragonfly (df) optis catheter to the target left anterior descending (lad) coronary artery lesion.It was buckling [prolapsing] into the left circumflex (lcx) coronary artery, despite multiple attempts due to challenging vessel anatomy (sharp turn into the lad).Only the tip of df catheter reached the lad.After multiple attempts to deliver it, the df catheter was removed from the patient.After they put the guideliner into lad; they were able to advance the df catheter to the lad and performed one successful pullback.When the df catheter was removed, they noticed there was staining of contrast in the proximal lcx.The lcx was dissected from proximal to mid lcx.The lcx was stented to successfully treat the dissection.The lad procedure was completed without the df catheter.The patient had elevated blood pressure that resolved with medication.The physician stated she should not have pushed so hard to deliver the catheter.The df catheter caused the dissection from the catheter being pushed and prolapsing into lcx.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 instructions for use as a known complication that may occur as a consequence of intravascular imaging.Based on the information provided, the reported difficulty appears to be due to the circumstances of the procedure.It is likely that while advancing against resistance within the challenging anatomy, the distal window tube bent causing the distal end of the catheter to prolapse.It is also likely that the excessive force applied during an attempt to cross the dragonfly caused the reported vascular dissection.The unexpected medical intervention, high blood pressure, and treatment with medications 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: 17240829
• MDR Text Key: 318267548
• Report Number: 2024168-2023-07008
• 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
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8957540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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
• Treatment: GUIDELINER
• Patient Outcome(s): Required Intervention