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 01/27/2022

Event Type  malfunction  

Event Description

It was reported that the dragonfly catheter was used with a bmw guide wire but after scanning it was not possible to remove the device from the patient anatomy and it had to be removed along with the bmw guide wire.The physician thought the issue may have been due to the guide wire port because the bmw guide wire was able to be removed from the dragonfly opstar catheter outside of the patient anatomy and only from the tip of the catheter.The procedure was completed without oct.There was no adverse patient effect and no reported 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.

Event Description

Returned device analysis of the dragonfly opstar catheter releaved that the guide wire exit notch was stretched and torn distally for a length of 4mm.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.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 guidewire 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: 13552939
• MDR Text Key: 289183410
• Report Number: 2024168-2022-01679
• 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,Followup
• Report Date: 07/29/2022

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 Expiration Date: 10/30/2023
• Device Catalogue Number: 1014652
• Device Lot Number: 8192787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2021
• 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