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

Model Number C408645

Device Problems No Display/Image (1183); Material Split, Cut or Torn (4008)

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

Event Date 05/23/2022

Event Type  malfunction  

Event Description

It was reported that the dragonfly optis imaging catheter was unable to connect during the procedure [no image].Therefore, the imaging catheter was removed, and another unspecified catheter was used to complete the procedure.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.Device return revealed the guidewire exit notch was torn for a length of 2mm.No additional information was provided.

Manufacturer Narrative

A query of the complaint handling database for the reported lot was performed and revealed no other complaints reported from this lot.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 device.However, an optical fiber test was performed which revealed an optical fiber fracture at the lens which can result in the imaging issue.It was also noted that the entire length of the window tube was stretched and the guidewire exit notch was torn; however, the damage is not related to the reported imaging issue.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 similar complaint reported from this lot.Based on the similar product investigation/complaint review, there is no indication of a lot specific product quality issue.The investigation determined that the reported imaging issue was 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 within the lens region.It is likely that during positioning or withdrawing the device within the anatomy/heavy stenosis, inadvertent damage to the optical fiber and the window tube occurred resulting in the reported 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: 15278950
• MDR Text Key: 303145397
• Report Number: 2024168-2022-09059
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 8385749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2022
• 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