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

Catalog Number 1014652

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896); Temperature Problem (3022)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in moderately stenosed left anterior descending artery.The dragonfly opstar imaging catheter was connected to the doc; however, calibration was not performed and the connection portion of the device became heated.No image was seen.The device was detached from the doc, and a second dragonfly opstar was used to continue and complete the procedure without adverse patient effect.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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.Based on the information provided, a definitive cause for the reported event could not be determined.It may be possible that the catheter was experiencing excess abnormal vibrations (possibly due to a bent nitinol tube/torque-wire) or poor image quality was being rendered (possibly due to optical fiber damage or contaminated optical end face), inadvertently caused the system/drive-motor optical connector (doc) to run longer than expected or the doc was compensating excess vibrations caused by a bent catheter¿possibly causing the doc to become warmer than expected; however, these conditions could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem codes 3022 and 2896 were removed.H6: health effect - impact code 2199 was removed.

Event Description

Subsequent to the previously filed report, additional information was received that it was the drive-motor optical controller (doc) that became heated and warmer than usual, not the dragonfly opstar catheter.Calibration was not performed as the issue occurred prior to calibration.No error message was seen.The catheter was not yet in the patient when this occurred.The doc did not become warmer than usual during use with the second dragonfly.No additional information was provided.

• 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: 14085777
• MDR Text Key: 289601288
• Report Number: 2024168-2022-03923
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192019
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Catalogue Number: 1014652
• Device Lot Number: 8220686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 77 KG