MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY OPSTAR IMAGING CATHETER; DIAGNOSTIC IMAGING CATHETER

Catalog Number 1014651

Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported that the dragonfly opstar imaging catheter was successfully used in the left anterior descending (lad) artery during pre-percutaneous coronary intervention (pci); however, the following error message was displayed "replace catheter" during post-pci.An optical fiber break was suspected, because there was no image displayed.The imaging catheter was removed and the procedure was completed without a replacement device.It was noted that the device was expired; however, the account was unaware that the imaging catheter had expired.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.Based on the information provided, a definitive cause for the reported imaging loss could not be determined.It may be possible that, during preparation/use, the device was inadvertently damaged causing a fracture within the optical fiber of the catheter.Furthermore, an optical fiber fracture may have caused the loss of imaging.However, without having the device to examine, this could not be confirmed.It should be noted that the dragonfly opstar instruction for use references the ¿use by¿ date symbol which is available on the product label to indicate the product expiration date.The expiration date for this device was august 22, 2023.The expiration date of the product is important for the sterility, efficacy, and performance of the device.In this case, there were no issues reported because of using the expired dragonfly.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: device code 2017 clarifier - use after expiration.

• Brand Name: DRAGONFLY OPSTAR IMAGING CATHETER
• Type of Device: DIAGNOSTIC IMAGING 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: 17769713
• MDR Text Key: 323787186
• Report Number: 2024168-2023-10203
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: 05415067031129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2023
• Device Catalogue Number: 1014651
• Device Lot Number: 8101543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2021
• 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: 70 YR
• Patient Sex: Male