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 03/09/2022

Event Type  malfunction  

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.

Event Description

It was reported that the dragonfly was difficult to remove from the 6 french guide catheter.It was able to be removed manually but there was a lot of friction felt.There were no adverse patient effects.A new dragonfly was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported difficulty removing the catheter was able to be confirmed; however, a conclusive cause of the difficulty could not be determined due to device condition.A dimensional analysis was performed.It was determined that the diameter of splice region of the catheter and non-abbott guidewire met the specification; however, a torn guide wire exit port was noted on the returned dragonfly.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 revealed no other similar incidents.The investigation determined that the difficulty was 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.It is likely that either the patient¿s anatomical condition(s) or the guide wire condition affected the withdrawal.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: 13981323
• MDR Text Key: 288998610
• Report Number: 2024168-2022-03489
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Catalogue Number: 1014652
• Device Lot Number: 8184981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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 CATHETER: 6F LAUNCHER MEDTRONIC; GUIDE WIRE: SION BLUE