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

Model Number 1014652

Device Problems Difficult to Insert (1316); Material Separation (1562); Material Deformation (2976)

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

Event Date 09/23/2021

Event Type  malfunction  

Event Description

During the procedure, the stent was malapposed and not well expanded, so ballooning was performed.Oct was used after stenting, but the catheter could not cross the stent.The catheter and guidewire were removed together and angiography was performed.The catheter was found to be damaged, but no additional pieces were left in the patient.There were no patient consequences.During analysis of the device, the proximal marker was found to be missing.

Manufacturer Narrative

One dragonfly opstar imaging catheter was received for evaluation.The results of the investigation concluded that the distal end of the catheter sheath had been kinked and stretched between the guidewire exit port and the distal end of the catheter sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Although the exact cause of the reported event remains unknown, positioning issue is consistent with the catheter damage.The cause of the catheter damage is consistent with damage during use.

• Brand Name: DRAGONFLY OPSTAR¿
• Type of Device: DRAGONFLY OPSTAR IMAGING CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ABBOTT VASCULAR; 4 robbins drive; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591 ; 9519143996
• MDR Report Key: 12831120
• MDR Text Key: 282046629
• Report Number: 3009600098-2021-00025
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2022
• Device Model Number: 1014652
• Device Lot Number: 7910798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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