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

Catalog Number C408641

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was performed in the de novo 90% stenosed, mildly tortuous, and mildly calcified lesion in the distal right coronary artery.A bmw elite ii guide wire was advanced and a dragonfly optis imaging catheter over it; however, when attempting to remove the dragonfly catheter they became stuck.Both devices were removed together and once outside the patient anatomy it was noted that the catheter was kinked.The procedure was successfully completed with a non-abbott guide wire and intravascular ultrasound.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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.Based on the information provided, the reported difficulty appears to be due to circumstances of the procedure.It is likely that the dragonfly catheter was inadvertently damaged while attempting to maneuver the device under challenging anatomical conditions.Furthermore, the kink on the dragonfly may have caused resistance between the guidewire and the dragonfly contributing to the difficulties removing the device, 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.The bmw elite ii guide wire referenced in is filed under a separate medwatch report number.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR 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: 15116363
• MDR Text Key: 304618188
• Report Number: 2024168-2022-08245
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Catalogue Number: C408641
• Device Lot Number: 8434049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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: HYPERION AL0.75; GUIDE WIRE: BMW ELITE II
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 65 KG