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

Model Number C408646

Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 - use after expirationna.

Event Description

It was reported the dragonfly optis imaging catheter was to be used in the proximal right coronary artery (prca) lesion with heavy tortuosity and tight lesion.The imaging catheter was pushed hard in the lesion due to resistance of the lesion.The imaging catheter crossed the lesion, however, a kink occurred.It was noted that an error message was displayed "imaging catheter failed unload the catheter manually" which indicates image was lost during live mode.Therefore, the imaging catheter was removed and another dragonfly optis imaging catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Device return analysis revealed that the dragonfly optis imaging catheter used in the procedure was expired.No additional information was provided.

Manufacturer Narrative

Visual analysis and optical fiber testing were performed on the returned device.The reported difficult to advance, deformation due to compressive stress, and no display/image were unable to be confirmed due to the condition of the returned device.The dried contrast prevented functional testing to verify the reported issue.However, an optical fiber test was performed which revealed an optical fiber fracture in the lens region.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 other similar complaints reported from this lot.The device was used after the expiration date.It should be noted that the dragonfly optis instruction for use references the ¿use by¿ date symbol which is available on the product label to indicate the product expiration date.The expiration date for this device was october 15, 2020.The expiration date of the product is important for the sterility, efficacy, and performance of the device.In this case, there were no issues reported because of using the expired dragonfly.The investigation determined that the reported difficult to advance, deformation due to compressive stress, and no display/image were related to circumstances of the procedure.Based on the information provided and analysis of the returned device, the reported kink appears to be due to challenging patient anatomy.It is likely that, while attempting to cross the lesion against resistance, the device was inadvertently damaged causing the device to deform/kink and resulting in the reported error/loss of imaging.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

N/a.

• 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: 16953382
• MDR Text Key: 315469458
• Report Number: 2024168-2023-05292
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 6657805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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