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

Model Number C408646

Device Problem Difficult to Remove (1528)

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

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The pressurewire x referenced is filed under a separate medwatch report number.

Event Description

It was reported that the pressurewire x,(pwx) device was advanced to the left anterior descending (lad) artery with mild tortuosity.The lesion was successfully treated with an unspecified balloon, subsequent to an unspecified stent.The pwx device remained in the patient and then a dragonfly optis imaging catheter was advanced to the treated lesion to verify proper stent placement.After the first pullback, the run did not look right due to unintended movement of a non-abbott guide catheter that led to blood flow to swirl.Therefore, the pwx device was advanced further distally; however, the imaging catheter was stuck with the pwx device.Both the pwx device and imaging catheter were removed as a single unit.Once both the pwx device and imaging catheter were outside the patient, the pwx device was able to be separated from the imaging catheter.It was noted that the tip of the pwx device was extremely curled.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.The procedure was completed with a non-abbott device.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned devices.The reported difficulty removing was unable to be confirmed due to the device condition.Additionally, the dragonfly guidewire exit notch was noted to be stretched and torn distally.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 similar complaints reported from this lot.Based on the information received and analysis of the returned device, the investigation was unable to determine a cause for the reported difficulties.It may be possible that, during the procedure, the pressurewire was inadvertently kinked while attempting to advance.Furthermore, it may be possible that the noted kink on the pressurewire caused the dragonfly to become inadvertently caught on the guidewire.The stretched and torn guidewire exit notch suggests that the guidewire and catheter were likely spread apart during removal.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.D4: lot number.

• 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: 15439923
• MDR Text Key: 301931164
• Report Number: 2024168-2022-09808
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: C408646
• Device Catalogue Number: C408645
• Device Lot Number: 8324167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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 Age: 69 YR
• Patient Sex: Male