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

Model Number	C408645
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported failure to advance was unable to be confirmed due to the condition of the returned unit.Additionally, the exit notch was noted to be torn.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.The investigation determined that the reported failure to advance was likely related to circumstances of the procedure.It is likely that anatomical conditions prevented the ability to cross and during the failure to cross, the interaction of the device with the guide wire resulted in the noted torn exit notch.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery.The dragonfly optis imaging catheter was used during the procedure; however, the device was unable to cross to the target lesion.The device was removed and replaced with a second same device to continue and complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.Returned device analysis noted a tear in the guidewire exit notch.No additional information was provided.

• 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: 16820681
• Report Number: 2024168-2023-04387
• Device Sequence Number: 20579858
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 07/31/2024
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 8587895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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