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

Catalog Number 1014652

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported the distal part of the dragonfly opstar imaging catheter was found to be broken and could not be placed.Its unknown at this time how the procedure was completed.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Event Description

Subsequent to the initially filed medwatch report, additional information was received.It was reported the distal part of the dragonfly opstar imaging catheter was kinked therefore it could not be placed in the lesion.The procedure was completed without using imaging.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported deformation was confirmed.Visual examination revealed kinks near the distal end of the device.Additionally, the rfid (radio frequency identification device) revealed the catheter had performed two (2) pullbacks.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 did not indicate a lot specific quality issue.The investigation determined that the reported deformation was related to circumstances of the procedure.Based on the information provided and analysis of the returned device, it is likely that the device was inadvertently damaged/kinked during preparation/use resulting in the noted kinks.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6- medical device problem code 1069 was removed and code 2889 was added.

• 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: 18394135
• MDR Text Key: 331340081
• Report Number: 2024168-2023-14453
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014652
• Device Lot Number: 9240479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2023
• 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