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

Model Number C408646

Device Problems Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that after successful pullback with the dragonfly imaging catheter, an error (pop up window) with the error imaging catheter failure (124) appeared during image generation.The system started to restart, after restarting the entire system operator tried to reconnect the same catheter without success.Connection failure (395), cal -002 was displayed.There were no adverse patient effects and no clinically significant delay during the procedure.Return device analysis observed the window tube was torn for a length of approximately 6mm.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

Visual inspection and optical fiber testing were performed on the returned device.The reported communication or transmission problem was unable to be confirmed due to the condition of the returned device (dried contrast within the sheath).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 determined that the reported communication or transmission problem was related to circumstances of the procedure.Based on the information provided and analysis of the returned device, it is likely that the observed optical fiber break caused the reported connection issue/difficulties.It is also likely that either the patient¿s anatomical condition(s) or use technique(s) employed caused the optical fiber break; however, this could not be confirmed.Additionally, there was unrelated ballooning, wrinkling, and stretching which resulted in a tear noted on the window tube of the catheter sheath.It was reported that the observed tear was not present during the procedure.The damage (ballooned, twisted, and torn sheath) was determined to be unrelated, and the result of post-procedure handling.The stretched guidewire exit notch suggests that the guidewire and catheter were likely spread apart during removal.It should also be noted that there was a successful connection and a successful pullback registered on the returned device.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: 17232907
• MDR Text Key: 318280605
• Report Number: 2024168-2023-06981
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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: 8867905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG