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 Problem Vascular Dissection (3160)

Event Date 07/13/2022

Event Type  Injury  

Event Description

It was reported that the dragonfly optis was unable to cross the target lesion in the moderately calcified and tortuous lesion in the left anterior descending (lad) artery.A second guide wire was used to assist in advancement of the dragonfly but it prolapsed at the proximal lad.While trying to cross the distal lad lesion the dragonfly catheter prolapsed, but was able to cross.During the first pullback two dissections were visible in the proximal and distal lad.Three xience stents (3.0x18, 3.5x23, 2.75x18) were implanted to treat the dissections.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

Visual and dimensional analysis were performed on the returned device.The reported difficult to advance and material too soft/flexible was unable to be confirmed due to the condition of the device.Visual analysis revealed multiple kinks in the window region 3mm distal to the lens.There were no other anomalies noted to the dragonfly.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 similar complaints reported from this lot.The investigation was unable to determine a cause for the reported difficult to advance and material too soft/flexible.It may be possible that challenging patient anatomical geometry affected the maneuverability of the device resulting in the difficulty advancing and subsequent device prolapse.However, this could not be confirmed.The patient effect of arterial dissection is listed in the instruction for use as a known adverse effect of intravascular imaging.A cause for the reported patient effect(s) of dissection and unexpected medical intervention, 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: 15164864
• MDR Text Key: 297245586
• Report Number: 2024168-2022-08551
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8363621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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
• Treatment: GUIDEWIRE: BHW 190 CM; GUIDEWIRE: BMW II 190 CM (X 2)
• Patient Outcome(s): Required Intervention