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 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The ht-bmw universal 190cm j device referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a lesion in the mid left anterior descending (lad).The bmw universal guidewire was advanced to the distal lad and into a small diagonal branch.The dragonfly opstar imaging catheter was advanced and an optical coherence tomography (oct) run was obtained.When removing the oct catheter, the guidewire was unintentionally withdrawn with the dragonfly catheter to the point that the coil of the guidewire was inside the rapid exchange portion of the dragonfly catheter and the guidewire tip was observed to have separated.A fluoroscope was used to locate the separated tip, it was retained inside the proximal shaft of the guiding catheter and inside the hemostatic valve.The hemostatic valve with the coil tip in it, were removed.It is believed that when the dragonfly catheter was removed the bmw coil prolapsed, and became entangled in the dragonfly catheter.When the doctor withdrew the dragonfly catheter, the guidewire withdrew with it, all the way into the guide catheter.When the dragonfly catheter was removed from the hemostatic valve, the coil of the wire separated and remained inside the guide catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to procedural circumstances.It is likely that during the procedure, the clearance between the bmw universal guidewire and dragonfly opstar imaging catheter was reduced causing the devices to become stuck together.When the dragonfly catheter was withdrawn, the guidewire was unintentionally withdrawn with the dragonfly catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction - catalog # and lot # updated.

• 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: 17869667
• MDR Text Key: 324931901
• Report Number: 2024168-2023-10836
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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: 9119460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 100 KG