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

Catalog Number 1014652

Device Problem Difficult to Remove (1528)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The bmw guide wire is filed under separate medwatch report number.

Event Description

It was reported the procedure was performed in the right coronary artery.A bmw guide wire was inserted.Predilation was performed, then a dragonfly opstar catheter was inserted.However, while attempting to remove the catheter, it was observed the guide seemed blocked and was unable to be removed.Therefore, the catheter and the guide wire were removed all as one.A new wire was used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned devices.The reported difficulty removing the catheter was unable to be confirmed due to the device condition; however, damage to the dragonfly catheter which is consistent with the reported event was observed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the difficulties were likely related to circumstances of the procedure.The torn guide wire exit port noted on the returned dragonfly catheter suggests that the guidewire and catheter were likely spread apart during removal causing the guide wire to tear into the exit port of the dragonfly resulting in difficulty removing and damage to the guide wire tip coils.While the reported withdrawal issue could not be confirmed, it is likely that either the patient¿s anatomical condition(s) or the guide catheter size affected the withdrawal; however, this could not be confirmed.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: 14145893
• MDR Text Key: 289600743
• Report Number: 2024168-2022-04219
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Catalogue Number: 1014652
• Device Lot Number: 8211511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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: BMW GUIDE WIRE