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

Catalog Number C408641

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was performed in the angulated, mildly stenosed, and mildly tortuous lesion in the proximal left anterior descending artery.The dragonfly optis imaging catheter was advanced; however, resistance was felt with the anatomy.The catheter was passed through forcibly, and the distal tip was able to be advanced to 3cm proximal of the guidewire tip.There was no problem performing a pullback.When removing the catheter from the patient body, the guidewire came out along with the dragonfly.Outside of the patient, the guidewire had to be pulled with strong force in order to remove the guidewire from the catheter.The physician commented that if the catheter had been a dragonfly opstar, there would have been no problem passing through the lesion.The procedure was successfully completed with intravascular ultrasound.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned devices.The reported difficulty advancing, material too soft/flexible, and difficulty removing the catheter was unable to be confirmed; however, damage to the dragonfly catheter was noted which could be consistent with the reported event.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.Information from the field stated that the dragonfly catheter was inserted against heavy resistance.Instruction for use (ifu) for optis imaging catheter cautions the user ¿if resistance is encountered during advancement or withdrawal of the dragonfly optis imaging catheter, stop manipulation and evaluate under fluoroscopy.If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.¿.In this case the reported issues could not be directly attributed to advancing against heavy resistance.The investigation determined that the difficulties were likely related to circumstances of the procedure.The returned guidewire was noted to be kinked and bent in several locations.The returned catheter exit port stretching suggests that there was excess resistance experienced during use, caused by the guidewire enacting stress on the distal edge of the catheter¿s exit port¿which could result in difficulty advancing and removing the catheter.It is likely that either the patient¿s anatomical condition(s) or the guidewire¿s condition affected the delivery, withdrawal, and product experience (too flexible); however, 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.

• 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: 14859247
• MDR Text Key: 295901860
• Report Number: 2024168-2022-07041
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C408641
• Device Lot Number: 8418900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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
• Treatment: GUIDEWIRE: RUNTHROUGH, 0.014INCH