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

Model Number C408645

Device Problems Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported connection issue could not be confirmed due to device conditions.The investigation revealed that the nitinol tube and optical fiber had been fractured which could contribute to the reported connection issue.A stretch was noted on the window tube, and a torn was also noted on the guidewire notch.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 indication of a lot specific product quality issue.The investigation determined that the reported connection issue was likely due to the noted nitinol tube and optical fiber fracture.The noted stretch and torn were likely due to the guidewire during the withdrawal of the device.Meanwhile, the fracture likely occurred during preparation/insertion/withdrawal, and it may cause a connection issue which is consistent with error code 395 or cal-001 indicating that a connection issue occurred per the optis integrated system field service manual.It may also be possible that the dragonfly was not set up per the instructions for use.Setting up the dragonfly imaging catheter section instructs to take care in handling the dragonfly to prevent breaking in the fiber-optics within the catheter.Kinking and bending of the catheter can cause damage.While connecting, ensure the proximal catheter segment is straight and aligned with the doc.Never attempt to connect and operate the catheter while the catheter remains coiled within the hoop.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that during preparation when connecting the catheter to the doc the error message cal-001.Therefore, the catheter was replaced a new dragonfly oct catheter and the procedure was completed.There was no adverse patient effect.Based on the returned device analysis, the guidewire exit notch was torn for a length of 4mm.No additional information was provided.

• 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: 15810687
• MDR Text Key: 307284923
• Report Number: 2024168-2022-11681
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 8390296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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