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

Catalog Number 1014651

Device Problem Difficult to Remove (1528)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that after successful imaging with the dragonfly opstar imaging catheter when attempting to retract the guidewire from the dragonfly exit notch, the guidewire could not be removed from the dragonfly.The guidewire and the dragonfly were removed together.There was no issue retracting the dragonfly from the anatomy.There was no clinically significant delay in the procedure and no adverse patient effects.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 and dimensional analysis was performed on the returned devices.The reported difficulty removing was unable to be confirmed as the dragonfly was able to be advanced through a proxy guide wire with no resistance noted.The dragonfly was noted to be stretched distally 2.2 cm from the distal tip.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 unable to determine a cause for the reported difficulties.It may be possible that, during the procedure, the guide wire was inadvertently bent/damaged.Furthermore, it may be possible that damaged guidewire caused the dragonfly to become inadvertently caught.The noted stretching suggests that the guidewire and catheter were likely spread apart during removal.However, this could not be confirmed.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: 18220607
• MDR Text Key: 329158627
• Report Number: 2024168-2023-13134
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: 05415067031129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014651
• Device Lot Number: 9194750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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
• Treatment: GUIDEWIRE
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 99 KG