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

Catalog Number 1014651

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Activation Failure (3270)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that the dragonfly opstar catheter met some resistance as it tracked over the wire during advancement to the lesion.It did reach the lesion.This was used with the optis mobile cart, aptivue.The physician reported the resistance felt was normal and what would be expected with a short rx catheter.It was not known if the resistance was with anatomy or the wire.The dragonfly reached the uncalcified lesion in the mid left anterior descending coronary artery.The physician purged the dragonfly but did not see contrast remove blood from the lens.There was no contrast leak noted at the syringe connection.Contrast was injected a couple of times but it did not trigger pullback to happen.An injection was seen down the vessel, but was not seen on the oct screen.No error message was displayed.When the physician went to remove the dragonfly, it became stuck on the wire.Both the dragonfly and the wire were removed together as a single unit.There was no visible damage to the dragonfly when it came out of the body.Ivus (intravascular ultrasound) was used to complete the procedure.Once outside the body, the dragonfly had to be forcefully pulled to get it off the wire.Outside the anatomy, the sales representative was able to perform a pullback and did not see any blood or abnormality in the lens region.The physician intentionally manipulated the dragonfly post procedure, resulting in visible tip damage and damage to the guide wire exit port.There was no adverse patient effect and no clinically significant delay in the procedure.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 device.The reported difficulty removing the catheter, advancing the catheter, and activation failure were unable to be confirmed due to returned condition of the device and the operational context of the reported issues.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 difficulties advancing, difficulty removing the catheter, and activation/pullback failure were likely related to operational context.There were kinks noted to the returned catheter sheath as well as tearing to the guidewire exit notch which resulted in a separation of the distal tip, which is suggests there was difficulty positioning or withdrawing the catheter.It is likely that the observed condition and damage (kinks and torn guidewire exit notch) to the returned catheter contributed or caused the reported difficulty advancing and removing the catheter.The optical fiber of the returned device was revealed to have remained intact.There was one (1) successful pullback recorded on the returned device.The observed damage (torn sheath resulting in distal tip separation) was confirmed to have occurred after use, and during post-procedure handling.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: 18351805
• MDR Text Key: 330873794
• Report Number: 2024168-2023-14200
• 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: 01/26/2024

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: 1014651
• Device Lot Number: 10029114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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 Sex: Female