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

Model Number	DUO
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was performed in the left anterior descending artery that was mildly tortuous and calcified.A dragonfly duo imaging catheter was inserted, but in was observed on x-ray that a foreign body was on the tip of the device.The catheter was pulled back and it was observed the foreign body moved with the catheter.Therefore, the device was removed.No foreign body was observed in the anatomy on imaging after the catheter was replaced to continue the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 revealed no other similar complaints reported from this lot.Based on the information provided, a definitive cause for the foreign body on the tip of the catheter could not be determined.It may be possible that damage occurred to the tip and/or guidewire exit port during advancement giving the appearance of foreign material on the tip while observed on x-ray; however, without having the device to examine, 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.D9: device available for evaluation updated from yes to no.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported foreign body on the tip of the device was not confirmed.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 revealed no other similar complaints reported from this lot.Based on the information provided, a definitive cause for the foreign body on the tip of the catheter could not be determined.Returned analysis was unable to confirm the reported foreign body on the tip of the catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 - device available for eval updated from 'no' to 'yes'.H6 - codes 4114 and 3221 removed.Codes 10 and 213 added.H10 - additional mfg narrative: revised.

• Brand Name: DRAGONFLY¿ DUO IMAGING CATHETER
• Common Device Name: INTRAVASCULAR IMAGING 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: 14164122
• Report Number: 2024168-2022-04280
• Device Sequence Number: 5968823
• Product Code: NQQ
• UDI-Device Identifier: 00183739000708
• UDI-Public: 00183739000708
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093857
• 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,Followup,Followup
• Report Date (Section B): 09/21/2022

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: 05/14/2023
• Device Model Number: DUO
• Device Catalogue Number: C408644
• Device Lot Number: 7928178
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 09/12/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/16/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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