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

Catalog Number C408641

Device Problems Poor Quality Image (1408); Gas/Air Leak (2946)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the dragonfly optis imaging catheter was purged normally.It was attempted to be used in the right coronary artery lesion with 90% stenosis, moderate tortuosity, mild angulation and mild calcification.When the live view was selected before a pullback, the in vivo image appeared dark.Due to the dark image, the physician suspected an air leak in the dragonfly.Purging of the dragonfly catheter was thought to be insufficient so the catheter was removed from the patient and purged a few times outside of the patient, but the issue persisted.Another catheter was used to continue and complete the procedure with no adverse patient consequences.The physician thought the issue might be due to the dragonfly itself since the catheter was purged normally.No additional information was provided.

Event Description

N/a.

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 identified revealed no other complaints reported from this lot.Based on the information provided, a definitive cause for the imaging issue and air/gas leak could not be determined.It is possible that improper syringe preparation may have occurred such as retracting the syringe during preparation causing air to take up space in the syringe or the syringe not being fully tightened, causing air to enter the device.It is possible that inadvertent rupture/damage may have occurred causing air to enter the device; however, without having the device to examine, this could not be confirmed.Based on the reported information, the suspected air leak may have contributed to the reported imaging issue.Potentially, inadvertent damage may have occurred on the optical fiber resulting in the reported imaging issue; however, without having the device to examine, 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¿ 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: 14844405
• MDR Text Key: 295886563
• Report Number: 2024168-2022-06971
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: C408641
• Device Lot Number: 8434042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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