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

Model Number C408645

Device Problem Difficult to Remove (1528)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported that this was a procedure in the left anterior descending coronary artery.Two pullbacks were performed using the dragonfly optis oct (optical coherence tomography) catheter on the balance middleweight (bmw) universal ii guide wire.The oct procedure was successfully completed.Some resistance was felt removing the dragonfly optis from the patient and it was noted that the spiral [tip] of the bmw guide wire was twisted on the distal part of the dragonfly optis.The broken guide wire was removed with the dragonfly.After removal, the tip of the guide wire was noted to be separated.It was confirmed that nothing remained in the patient.There were no adverse patient effects and no clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Date of event is estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device is expected to be returned for evaluation.It has not yet been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The bmw universal ii guide wire referenced is filed under a separate medwatch report number.

Event Description

Subsequent to the previously filed report, additional information was received that a total of three oct runs were performed.A little resistance was felt during removal of the dragonfly catheter.When the dragonfly catheter with the bmw guide wire was extracted from the guide catheter, the bmw guide wire was found broken at the level of the monorail part of the dragonfly catheter with the twisting of the residual part of the guide wire related to the monorail part.The oct analysis was successfully completed and the patient did not have any adverse effects.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported difficulty removing the catheter was unable to be confirmed due to the device condition; however, there was damage observed which could be attributed to the reported event.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the difficulties were likely related to circumstances of the procedure.The stretched guidewire exit port noted on the returned dragonfly catheter, as well as the condition of the returned guidewire, suggests that the guidewire damage was likely the cause of the reported difficulty to remove.The returned condition of the devices suggests that there was resistance encountered during removal, which would cause the guidewire to force itself into the distal edge of the guidewire exit port resulting in the aforementioned stretched guidewire exit port.While the exact cause of the reported withdrawal issue could not be confirmed, it is likely that the patient¿s anatomical condition(s) or the condition of the guidewire being used affected the catheter¿s withdrawal; 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: 14518064
• MDR Text Key: 292799869
• Report Number: 2024168-2022-05669
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 8324185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2022
• 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
• Treatment: BALANCE MIDDLE-WEIGHT UNIVERSAL II GUIDEWIRE.