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

Catalog Number UNK DRAGONFLY OPSTAR

Device Problem Difficult to Remove (1528)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure, the dragonfly opstar imaging catheter was advanced over an unspecified balanced middle weight (bmw) guide wire (gw) and used without reported issues.After use, while attempting to remove the device from the anatomy, the dragonfly opstar became stuck with the bmw guide wire.The dragonfly and bmw devices had to be removed as a single unit as the devices could not be separated and could not be used with any other devices.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record was unable to be performed as there was no batch/lot number provided.Additionally, a review of the complaint history was also unable to be performed due to the lack of batch/lot.Based on the information provided, the reported difficulty removing the catheter appears to be due to circumstances of the procedure.It is likely that the patient anatomical condition(s) or use techniques employed caused the difficulty removing the catheter; however, this could not be confirmed.It could be that the guidewire being used became damaged or inadequately performed; however, these conditions also could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional dragonfly opstar device referenced in b5 is filed under separate medwatch report number.

• 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: 18440283
• MDR Text Key: 331928636
• Report Number: 2024168-2024-00116
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/03/2024

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: UNK DRAGONFLY OPSTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/03/2024
• 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