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

Model Number C408646

Device Problems Communication or Transmission Problem (2896); Gas/Air Leak (2946)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

It was reported that during flushing of the dragonfly optis catheter, it was noted that the catheter was not recognized by the system and air bubbles were coming back in the 3 ml syringe.The connection between the 3 ml syringe and catheter were confirmed to be secure.The operating room team unplugged everything then reconnected but the catheter was still not recognized.Another dragonfly optis catheter was used to complete the procedure.There were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported connection issue and gas leak was unable to be confirmed due to the condition of the returned device.However, the rfid (radio frequency identification device) chip was read which revealed that the catheter had been successfully connected to the system.Additionally, an optical fiber test revealed an optical fiber fracture in the window region of the catheter.Dimensional analysis confirmed that the purge hole was within specification.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.Based on the information received and analysis of the returned device, the investigation was not able to determine a definitive cause for the reported communication or transmission problem or gas leak.It may be possible that, during device preparation, the syringe was pulled instead of pushed causing air to flow from the x-ring retainer into the syringe.However, due to the dried contrast, this could not be confirmed.Furthermore, it may be possible that during use, the device was inadvertently damaged causing the noted optical fiber fracture in the window region resulting in the reported communication failure.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: 15440054
• MDR Text Key: 300884693
• Report Number: 2024168-2022-09810
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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: 8485031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2022
• 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