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

Catalog Number C408646

Device Problems Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis, functional analysis, and optical fiber testing were performed on the returned device.The reported connection issue was not confirmed.The catheter was connected to the doc successfully.The catheter was able to connect and proceed to live-view mode.An optical fiber test was performed, which revealed the optical fiber remained intact.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 similar complaints reported from this lot.The investigation was unable to determine a cause for the reported connection issue as the returned unit functioned as intended.Additionally, scan of the rfid read that there had been 3 load counts and 5 pullbacks performed at the account which contradicts the reported information that the imaging catheter failed to connect.The dragonfly optis instruction for use lists a ¿use by¿ icon which indicates that the device is to be used prior to the expiration date on the product label.It could not be determined if using the device after the expiration date contributed to the difficulties and the returned device analysis found no issues with the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: device code 2017 clarifier- use after expirationna.

Event Description

It was reported that during the procedure, the dragonfly optis imaging catheter was intended to be used in the left anterior descending artery (lad) with moderate calcification and heavy tortuosity.However, after the imaging catheter crossed the lesion the imaging catheter failed to connect, cal-002 error code displayed.Therefore, the imaging catheter was removed from the patient, and the procedure was completed with another dragonfly optis imaging catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.It was noted the device was used past the expiration date.

• 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: 17450492
• MDR Text Key: 320345465
• Report Number: 2024168-2023-08385
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: C408646
• Device Lot Number: 7655820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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