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

Catalog Number 1014652

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The bmw guide wire referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a lesion in the distal right coronary artery (drca).An unknown bmw guide wire (gw) was advanced with resistance with the anatomy and could not be advanced any further within the target lesion due to distal stenosis.The dragonfly opstar catheter was advanced without issue over the bmw guide wire; however, resistance was felt during advancement into the vessel.Optical coherence tomography (oct) was performed without issue; however, when removing the dragonfly opstar catheter, the bmw gw was pulled out of the vessel as well so both devices were removed together.The guide wire was then inspected, revealing that it was separated into multiple pieces.No separated pieces remained in the anatomy.A new guide wire was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined that the reported difficulty advancing and removing the device appears to be related to operational context.Based on the reported information, it is likely that the challenging anatomical conditions were the result of the difficulty to advance.Further manipulation against resistance likely caused the guide wire to kink or became damaged causing the difficulty to remove from the dragonfly and ultimately resulting in the core separation.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: 13564093
• MDR Text Key: 286852051
• Report Number: 2024168-2022-01734
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 04/21/2022

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: 1014652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/21/2022
• 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
• Treatment: 6F GUIDE; GUIDE WIRE: BMW