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

Model Number C408646

Device Problems Material Separation (1562); Connection Problem (2900)

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

Event Date 02/08/2022

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.

Event Description

It was reported that the dragonfly catheter seemed not to lock into the drive-motor optical controller (doc) and when ejected part of the catheter shaft had separated.A decision not to proceed with optical coherence tomography (oct) was made as there was uncertainty with the optis mobile system.There was no patient involvement.The procedure was continued without imaging and there was no adverse patient effect.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported connection problem was unable to be confirmed due to the condition of the returned unit.The material separation was confirmed as the nitinol tube was separated and the device was returned into two pieces.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 was unable to determine a cause for the reported difficulties.It may be possible that the optical connector on the dragonfly catheter was not properly aligned with the drive-motor optical controller (doc) during insertion resulting in difficulty locking and when ejected, the inner shell remained connected to the doc as the outer shell was pulled out causing the nitinol tube to fracture.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: 13637393
• MDR Text Key: 287587682
• Report Number: 2024168-2022-02103
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8045496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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