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

Model Number C408646

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Calibration Problem (2890); Material Split, Cut or Torn (4008)

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

Event Date 04/17/2022

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported connection problem was unable to be confirmed due to the condition of the returned unit.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 complaints reported from this lot.Based on the evaluation of the returned device, the investigation determined that the reported difficulties (the failure to advance, kink, and calibration problem) were likely, related to circumstances of the procedure.It is likely that during the failed attempt to advance, the catheter became kinked causing the noted optical fiber fracture in the lens region and resulting in the reported error message/loss of imaging.The guide wire exit notch was torn and stretched for a length of 1.3 millimeters, likely due to interaction with the guide wire.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 the dragonfly optis catheter was not able to cross the heavy calcified left anterior descending coronary artery after post-dilation.The catheter became kinked and calibration error cal-002 was displayed.The catheter stopped working.Another catheter was used to complete the procedure.There were no patient consequences.No additional information was provided.Return device analysis identified that the guide wire exit notch was torn and stretched.

• 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: 15214827
• MDR Text Key: 302514573
• Report Number: 2024168-2022-08703
• 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
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8171772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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