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

Catalog Number 1014651

Device Problems Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported material deformation was confirmed.Visual examination revealed a stretched, smashed, and torn guide wire exit notch.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 material deformation was related to circumstances of the procedure.Based on the information provided and analysis of the returned device, it is likely that the interaction with the versaturn guidewire and complex patient anatomy contributed to the reported difficulties.Analysis of the versaturn guidewire found that the top coils were misaligned.It is likely that the misaligned coils impacted the guide wire¿s ability to move through the guide wire exit notch on the opstar.Furthermore, it is likely that this misalignment contributed to the noted damage to the opstar¿s guide wire exit notch.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional dragonfly and ht versaturn devices referenced in b5 are filed under separate medwatch report numbers.Na.

Event Description

It was reported that during the procedure two dragonfly opstar¿ imaging catheters were intended to be used in the proximal left anterior descending artery (lad) lesion.The first imaging catheter was used with a 190 versaturn guidewire.However, during the second pull back (post stenting) the guide wire came out of the exit notch.The dragonfly and guide wire were removed without issues.The dragonfly was inspected outside of the anatomy, there was no visible damage to the catheter, only that the exit notch had a rough feel when touched with finger.A new dragonfly opstar and new versaturn guide wire were used however, during pullback the imaging catheter and the guidewire curled up together.The versaturn guide wire and the imaging catheter will be returned stuck together.The devices were removed as a single unit.The procedure was completed with no complications, optical coherence tomography images were obtained and had good results.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.(b)(4): returned goods lab observed a tear on the exit notch.

• 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: 17675040
• MDR Text Key: 322719031
• Report Number: 2024168-2023-09585
• 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: 09/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014651
• Device Lot Number: 9023441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 81 KG