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

Catalog Number	C408646
Medical Device Problem Codes	Poor Quality Image (1408); Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pressurewire x, wireless device was to be used in the left anterior descending (lad) lesion with heavy calcification.Resistance was felt during advancement.A first run was performed and a dissection was confirmed in the mid distal segment.The dissection was treated with a stent.A second run was performed, however, the images were unclear.The doctor suspects fiber optic damage caused by the calcification.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record could not be performed as the device was not returned for evaluation and the lot number was not provided.Additionally, a review of the complaint history could not be completed as the device was not returned and the lot number was not provided.Based on the information provided, the reported difficulty advancing resulting in poor image quality appears to be due to circumstances of the procedure.It is likely that challenging anatomical conditions caused resistance during advancement.A definitive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The unexpected medical intervention appears to be related to circumstances of the procedure.The reported patient effect of dissection is listed in the dragonfly optis instructions for use as known potential complications which may be encountered during the procedure.In this case, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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: 17966874
• Report Number: 2024168-2023-11574
• Device Sequence Number: 15158161
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• 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
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C408646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown