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

Model Number C408646

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional dragonfly optis device referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported that the dragonfly optis imaging catheter and the pressurewire x, wireless (pwx) device were intended to be used in the left anterior descending artery (lad) lesion with mild calcification and tortuosity.The pwx device was advanced to the target lesion without issue.However, the distal marker of the imaging crossed into the radiopaque portion of the pwx device.Therefore, the imaging catheter was removed, but then the radiopaque portion of the pwx device had looped around the imaging catheter resulting in the pwx device to be removed along with imaging catheter.The procedure was completed with another unspecified device.There was no adverse patient effect and no clinically significant delay in the procedure.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 indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported difficult to remove and activation, position, or separation problem.It may be possible that the user¿s technique when removing the dragonfly over the guide wire may have contributed to the inadvertent interaction between the devices, resulting in the reported difficult to remove.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 15883164
• MDR Text Key: 306805175
• Report Number: 2024168-2022-12016
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8588107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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