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

Model Number C408646

Device Problems Material Separation (1562); Communication or Transmission Problem (2896)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 procedure was performed in the right coronary artery.During the study, the dragonfly imaging catheter gave a normal reading and was therefore inserted into the anatomy.However, while in the anatomy an error message occurred requesting the catheter to be disconnected.After removal of the catheter and on disconnection, a rupture was observed in the connection area with the transducer.The catheter was replaced to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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; however, the material separation was able to be confirmed as the nitinol tube was separated and the device was returned into two pieces¿which could also cause the reportable connection issue.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 reported connection issue and material separation were related to circumstances of the procedure.Based on the evaluation of the returned device, the observed optical fiber/nitinol tube break likely occurred from excessive bending of the strain relief during use¿which could contribute/cause to connection issues, 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: 15414808
• MDR Text Key: 305248082
• Report Number: 2024168-2022-09671
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7990032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 85 KG