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

Model Number C408646

Device Problems Device Difficult to Setup or Prepare (1487); Communication or Transmission Problem (2896)

Patient Problems Non specific EKG/ECG Changes (1817); Vasoconstriction (2126); Cardiogenic Shock (2262)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was performed in the mid circumflex.It was noted the patient had mitral valve stenosis.During preparation of the dragonfly imaging catheter, it was observed that contrast was continuously flowing out of the device, rather than dripping.Although this was observed, the physician decided to continue the procedure without replacing the device.The catheter was inserted and advanced to the target lesion.However, the patient had a coronary spasm with an st elevation, followed by shock.The physician was unable to determine if the catheter caused or contributed to these patient effects.An error message then occurred stating the catheter needed to be disconnected.Therefore the device was removed.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported connection issue was unable to be confirmed due to the condition of the returned device.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 reported patient effect of coronary artery spasm is listed in the dragonfly optis instruction for use as a known complication that may occur as consequence of intravascular imaging and catherization procedures.In this case, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information received and analysis of the returned device, the investigation was not able to determine a definitive cause for the reported communication or transmission problem or device difficult to set up or prepare.It may be possible that, during device use, the internal optical fiber was inadvertently damaged causing the reported communication or transmission problem.However, this could not be confirmed to the returned condition of the device.Additionally, a conclusive cause for the reported patient effects, 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
• 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: 14553791
• MDR Text Key: 293078825
• Report Number: 2024168-2022-05822
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8324115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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
• Patient Outcome(s): Other
• Patient Sex: Female