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

Model Number C408645

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

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

Event Date 08/08/2022

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 tip of the dragonfly optis catheter was found detached (separated in two pieces) when the package was opened.No patient was involved.Another dragonfly optis catheter was used to finish the procedure successfully.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 be attributable to 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 similar 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.D4: lot no and expiration date.H4: manufacturing date.H6 - health effect - impact code 2645 was removed.

Event Description

Subsequent to the previously filed report, additional information was received.The device was returned with blood inside the device.The nitonol tube and opical fiber separated; there was no tip detachment.Follow-up with the account confirmed the initial information was reported incorrectly.The dragonfly optis catheter was inserted into the patient, but was removed from the doc because it could not connect to the system.It was the hub of the catheter that fractured outside of the patient.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: 15288487
• MDR Text Key: 305253434
• Report Number: 2024168-2022-09126
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 8010963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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