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

Catalog Number 1014652

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that the dragonfly opstar imaging catheter was used in the left anterior descending (lad) lesion with moderate stenosis and tortuosity.During post-percutaneous coronary intervention (pci), after pullback, the dragonfly was difficult to remove.The catheter was stuck on an implanted stent.The catheter was pushed and rotated and was able to be removed.The catheter was kinked, and the tip was noted to be flared.Therefore, another catheter was used to complete the procedure.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.A review of the lot history record was unable to be performed as there was no batch/lot number provided.Additionally, a review of the complaint history was also unable to be performed due to the lack of batch/lot.The reported difficulty appears to be due to circumstances of the procedure.Based on the reported information, it is likely that the patient anatomical conditions, guidewire employed was damaged or deficient, or use techniques employed caused the catheter to kink¿which caused the subsequent difficulty removing the catheter and material deformation (flared tip); 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.E1: (b)(6) hospital.

• 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: 17882081
• MDR Text Key: 325062218
• Report Number: 2024168-2023-10934
• 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
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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: 9006372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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