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

Model Number C408646

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

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

Event Date 02/16/2022

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.Na.

Event Description

It was reported that the diagnostic procedure was performed in the distal right coronary artery (pre-bifurcation) moderate to severe lesion.The dragonfly optis catheter was advanced without issue; however, when attempting to manipulate the catheter and pull it back, the catheter caught on the unspecified guide wire and damaged the tip of the catheter.The catheter was not able to be withdrawn despite having a significant length of guide wire in the posterior descending artery and beyond the distal dragonfly catheter.The catheter and guide wire were removed together.A new dragonfly optis catheter was used for the procedure.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned devices.The reported difficulty removing and damage to the distal tip was not able to be confirmed due to the device condition.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 investigation determined that the difficulties were likely related to circumstances of the procedure.The stretched guide wire exit port distal edge noted on the returned dragonfly catheter suggests that the guide wire and catheter were likely spread apart during removal causing the guide wire to stretch the exit port distal edge resulting in difficulty removing; however, this could not be confirmed.It is possible that the proximally device bend affected the maneuverability of the device; however, this also could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6.Code 1506 removed.

Event Description

Subsequent to the initial report, additional reported information indicates that the tip of the dragonfly catheter was kinked.

• 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: 13743108
• MDR Text Key: 288379134
• Report Number: 2024168-2022-02560
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7990146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 91 KG