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

Model Number C408646

Device Problems No Display/Image (1183); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 05/20/2022

Event Type  malfunction  

Manufacturer Narrative

The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A query of the complaint handling database for the reported lot was performed and revealed no other complaints reported from this lot.Based on the information provided, the reported difficulty advancing, difficulty removing, and loss of imaging appears to be due to the circumstances of the procedure.It is likely that the resistance encountered during advancement caused damage/kink to the device resulting in the reported difficulty advancing and removing.Additionally, while attempting to advance against resistance, damage to the optical fiber likely occurred resulting in 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

It was reported that a dragonfly optis imaging catheter was advanced to a lesion in the right coronary artery (rca) with moderate calcification and high tortuosity.It was noted resistance was felt due to the calcification.A decision was made to retrieve the catheter to pre-dilatate the lesion.However, the imaging catheter could not be retrieved due to the calcium, stenosis and tortuosity.After some time, the imaging catheter was able to be pulled out and removed safely.Then the lesion was pre-dilated with several unspecified balloons and the same imaging catheter was re-advanced to check the lesion.However, the image was not normal which indicated that the imaging catheter was damaged due to the calcification.Therefore, the imaging catheter was removed and the procedure continued with another unspecified imaging catheter and the lesion was treated with a drug-coated balloon to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 14686942
• MDR Text Key: 294769434
• Report Number: 2024168-2022-06356
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7786332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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