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

Model Number C408646

Device Problems Poor Quality Image (1408); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a target lesion in the mildly calcified and tortuous right coronary artery (rca).The dragonfly optis imaging catheter was used successfully during pre-percutaneous coronary intervention (pci).An unspecified stent was implanted and post dilatation was performed.The dragnofly optis was then used for post-pci; however, difficulty was noted during advancement through the stented area.Pullback was performed; however, the image was not adequate and the stent was unable to be seen very well.A lens fracture was suspected.The dragonfly optis was removed with difficulty, thought to be related to the device itself.And the dragonfly catheter was bent.The device was able to be removed in one piece.There were no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual analysis and optical fiber testing were performed on the returned device.The reported imaging issue was unable to be confirmed due to the condition of the returned which had dried contrast throughout the device.However, an optical fiber test was performed which revealed an optical fiber fracture in the lens region.The reported difficulty to advance and remove could not be replicated in a testing environment as it was based on operational circumstances.Meanwhile, the reported bend/kink could not be confirmed as there was no bend/kink noted on the device.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 indication of a lot specific product quality issue.The investigation determined that the reported imaging issue, difficulty to advance, and difficulty to remove were related to the circumstances of the procedure.Based on the evaluation of the returned device, the difficulty appears to be due to the noted optical fiber fracture.It is likely the interaction between the stent and the catheter caused the reported difficulty to advance, difficulty to remove, and damage to the optical fiber resulting in the reported imaging issue.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: 15739852
• MDR Text Key: 304013321
• Report Number: 2024168-2022-11284
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8596002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 104 KG