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

Catalog Number 1014652

Device Problems Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported the dragonfly opstar imaging catheter was used to evaluate a newly placed stent.Pullback was done successfully and according to the optical coherence tomography (oct) image, stent apposition and expansion were perfectly fine.When attempting to remove the dragonfly opstar catheter, a lot of pressure had to be used.Unfortunately, this led to a longitudinal compression of the implanted stent and approximately 10-20mm of the distal part of dragonfly catheter separated inside the patient.Another stent was used to jam the separated segment between this new stent and up against the artery wall.The patient is doing fine.After discussion with three physicians, it is suspected a stent strut got stuck in the opening of the monorail catheter opening.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code 2017 added.The device was not returned for evaluation.A query of the corrective action tracking system for the web (catsweb) database for the reported lot revealed there is no indication of a lot specific issue.In this event, it was reported that excess pressure/force was applied against resistance when attempting to remove the catheter.The instruction for use (ifu) for opstar imaging catheter caution the user that ¿if resistance is encountered during withdrawal of the dragonfly opstar imaging catheter: - stop manipulation and evaluate under fluoroscopy¿.If the cause of the resistance cannot be determined or mitigated, carefully remove the dragonfly opstar imaging catheter and guide wire as a unit from the patient.¿.In this case, the user continued to pull against resistance which caused the subsequent damage and material separation.The reported difficulty to remove, material separation, and device damaged by another device was determined to be related to operational context.In this case, it is likely that the catheter or guidewire became caught on a portion of the stent¿which caused the reported difficulty to remove.The subsequent damage by another device and material separation were due to the excess force applied by the user to remove the catheter from the patient anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Based on the reported information and results of the complaint investigation there is no indication the reported difficulty to remove, material separation, and device damaged by another device are related to a potential product quality issue.

• 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: 18972353
• MDR Text Key: 338547667
• Report Number: 2024168-2024-03619
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention