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 01/28/2022

Event Type  malfunction  

Event Description

It was reported that an unknown balance middleweight (bmw) guide wire was easily placed and the dragonfly opstar imaging catheter was easily advanced into the vessel via the guide wire.When attempting the first pull back of the optical coherence tomography (oct) there was slight displacement at the proximal portion of the guide wire noted.When positioning for the second pullback with the catheter further proximally in order to be able to examine the distal main trunk, there was significant dislocation [kink] of the wire proximally with a step on the wire already visible near the distal end of the wire.Advancement of the bmw was no longer possible because the wire was still far enough distally.After the third pull back was performed, the catheter could not be removed; therefore, the bmw wire and catheter were removed together with resistance.The bmw guide wire was noted to have kinked twice.The procedure was completed without further oct.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The bmw guide wire is filed under a separate medwatch report number.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned devices.The reported difficulty removing was unable to be confirmed due to the device condition.The damage to the dragonfly catheter was confirmed and consistent with the reported difficult to remove.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.The investigation determined that the difficulties were likely related to circumstances of the procedure.It is likely that the reduced clearance between the inner diameter of the catheter lumen and the outer diameter of the guide wire caused the resistance.Furthermore, while attempting to reposition the device against resistance caused by the bent shaping ribbon and core, the guide wire exit port was stretched and torn.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: 13537375
• MDR Text Key: 288790563
• Report Number: 2024168-2022-01572
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Catalogue Number: 1014652
• Device Lot Number: 8035650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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: GUIDE WIRE: BMW.