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

Model Number C408646

Device Problems Difficult to Flush (1251); Material Split, Cut or Torn (4008)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of the dragonfly catheter, (lot# 8588107) the catheter was unable to purge, there were no drops exiting the catheter.Therefore, the catheter was not used.There was no patient involvement.A second dragonfly catheter (lot # 8588112) was being prepared but had not connection, an error code 395 was displayed; therefore, the catheter was not used.A third dragonfly catheter (lot#8611637) was prepared but had the same issue, no connection error code 395.A fourth dragonfly catheter was used successfully to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.The return device analysis of the dragonfly catheter, (lot# 8588107) noted that there was fluid leaking from a tear on the side arm tubing 13.5cm distal to the strain relief.No additional information was provided.

Manufacturer Narrative

Visual, functional, and dimensional analysis was performed on the returned device.The reported difficult to flush was confirmed, however, the difficulties observed were attributed to a leak found on the side arm tubing.A functional test revealed that the dragonfly was able to be purged, however, fluid was leaking from a tear on the side arm tubing 13.5cm away from the strain relief.The dimensional analysis confirmed that the inner diameter of the purge hole was within specification.The visual observation revealed that the catheter shaft was kinked at multiple locations approximately 49.5cm from the proximal end of the inner shell.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 complaints reported from this lot.Based on the information provided and analysis of the returned device, a definitive cause for the difficult to flush could not be determined.It may be possible that procedural contaminates/dried contrast obstructed flow while attempting to purge the catheter, or failure to follow procedural directions or guidelines within the instructions for use; however, these conditions could not be confirmed.Additionally, a definitive cause for the leak was also not determined.It may be possible that, during device preparation, the device was inadvertently damaged causing the leak on the side arm tubing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Visual analysis, functional testing, scanning electron microscopy (sem), additional testing methods, and dimensional analysis were performed on the returned device.The reported difficulty purging the catheter was unable to be confirmed, as the device functioned as intended.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the reported purge (flush) difficulty could not be confirmed, as the device functioned as intended.The catheter was returned with dried contrast visible throughout the window region and was initially unable to be purged due to the dried contrast.The catheter was then placed into a sonic water bath to remove the dried contrast.The catheter was then able to purge liquid repeatedly and as expected.It is possible that the condition/state/type of contrast used affected the device¿s purge/flush functionality, however, this information could not be confirmed.There were no visual anomalies nor dimensional errors noted, nor any issues other than the dried contrast which could be attributed to the reported difficulty purging.There was also a sheath leak noted from the sidearm tubing as well as an optical fiber break, but both were determined to be unrelated to the reported event and likely occurred from post-use handling/shipping conditions.The additional testing performed and the sem results both were unable to determine a cause or contributor to the reported purge issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6- medical device problem code 4008 and investigation conclusions code 61 were removed.H10 - additional mfg narrative: revised.

• 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: 15998995
• MDR Text Key: 306267166
• Report Number: 2024168-2022-12759
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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