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); Material Split, Cut or Torn (4008)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported that the dragonfly optis imaging catheter became kinked before crossing the lesion.The imaging catheter could not be advanced due to resistance, possibly due to the anatomy but this could not be confirmed.An unspecified guidewire was pulled back which ended with a loop and pulled the wire out.This required rewiring of the vessel.The imaging catheter was removed from the patient 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 guidewire exit notch was torn and stretched distally for a length of 1.5 millimeters.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported deformation under compressive stress and failure to advance was not able to be confirmed due to the condition of the returned device.However, the guidewire exit notch was noted to be torn and stretched distally for a length of 1.5 millimeters.Based on the information received and analysis of the returned device, the investigation was unable to determine a cause for difficulties encountered.It may be possible that, after encountering resistance in the attempt to cross the lesion, the device was damaged.Furthermore, during removal, the dragonfly may have gotten inadvertently caught on the guidewire.The stretched and torn guidewire exit notch suggests that the guidewire and catheter were likely spread apart during removal.However, this could not be confirmed.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: 15269995
• MDR Text Key: 305177325
• Report Number: 2024168-2022-08992
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8390275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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