MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY OPSTAR IMAGING CATHETER; DIAGNOSTIC IMAGING CATHETER

Catalog Number 1014652

Device Problem Difficult to Remove (1528)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported the turntrac and optical coherence tomography (oct) dragonfly opstar imaging catheter were delivered without any problems distal into the left anterior descending (lad) lesion.However, after the third successful image, removal of the dragonfly catheter was not possible, it was stuck with the turntrac guidewire.Both the turntrac and the dragonfly were removed together.The turntrac was inspected outside the patient anatomy, and it was observed that the distal tip of the turntrac was broken and it seems like the coils are not in the correct position.The turntrac was stuck in the oct dragonfly catheter.There were no adverse patient effects and no clinically significant delay.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.The additional hi-torque turntrac device referenced in b5 is filed under separate medwatch report number.Na.

Manufacturer Narrative

Visual analysis was performed on the returned devices.The reported difficulty removing was confirmed as the devices were returned frozen together.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided and evaluation of the returned devices, the difficulty removing was likely due to the damage noted on the distal portion of the turntrac guide wire.The noted bends and misaligned coils likely impacted the clearance between the guide wire and dragonfly catheter causing the devices to become stuck together and prevented the ability to remove the dragonfly catheter from the wire.Although a definitive cause for the guide wire damage could not be determined, this type of damage is consistent with interaction between the guide wire and the anatomy and/or associated devices during use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: DRAGONFLY OPSTAR IMAGING CATHETER
• Type of Device: DIAGNOSTIC IMAGING 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: 18822344
• MDR Text Key: 336746480
• Report Number: 2024168-2024-02655
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031112
• UDI-Public: (01)05415067031112(17)251019(10)10043976
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192019
• 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: 04/23/2024

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 Catalogue Number: 1014652
• Device Lot Number: 10043976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• 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