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

Catalog Number	C408646
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the dragonfly optis imaging catheter was to be used in the left main coronary artery (lm) and the left anterior descending (lad) artery.The device was pulled back into the catheter; however, the distal end of the device was stuck on the balanced middle weight (bmw) guide wire (gw), and the guide wire felt sticky when removing.There was no device separation or other damage noted.The devices were removed as a single unit.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional hi-torque balance middleweight device referenced in b5 is filed under separate medwatch report number.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The reported difficulty removing the catheter was unable to be confirmed.Lot history record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The investigation determined that the difficulties were likely related to circumstances of the procedure.The distal end of the guidewire exit notch was noted to be stretched, which suggests that either positioning or withdrawal difficulty were encountered during use but cannot be directly attributed as the cause for the difficulty to remove.There were no damages nor anomalies to the catheter which could be directly attributed to reported difficulty to remove.Based on the reported information of the guidewire feeling sticky during attempted withdrawal and the lack of catheter anomalies, it is likely that the difficulty removing the catheter was caused by operational context/patient anatomical conditions (contamination on guidewire, guidewire damage, heavy calcification, etc).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
• Common Device Name: 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: 18743859
• Report Number: 2024168-2024-02107
• Device Sequence Number: 6250321
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)251119(10)10079710
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2025
• Device Catalogue Number: C408646
• Device Lot Number: 10079710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown