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

Catalog Number 1014651

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

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

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as the device was not returned for evaluation and the lot number was not provided.Additionally, a review of the complaint history could not be completed as the device was not returned and the lot number was not provided.Based on the information provided, the reported difficulty appears to be due to circumstances of the procedure.It is likely that the difficulty removing was due to interaction with the stent.It may be possible that the stent was not fully apposed to the vessel wall causing the dragonfly to catch the stent edge.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Event Description

It was reported that the dragonfly optis imaging catheter was to be used in an unspecified lesion.During removal, there was resistance due to the imaging catheter being caught on the implanted stent.The stent edge was noted to be flared so an unknown balloon was used to fix the flared edge.The imaging catheter was removed with the guidewire as a single unit.The procedure completed without using a replacement.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

• 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: 18185600
• MDR Text Key: 328706574
• Report Number: 2024168-2023-12970
• 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
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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