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

Model Number 1014651

Device Problems Crack (1135); Gas/Air Leak (2946)

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

Event Type  malfunction  

Event Description

During the procedure, upon the second pull back there was air in the catheter it was believed that the catheter was cracked.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 13060072
• MDR Text Key: 283598893
• Report Number: 3009600098-2021-00029
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8127935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• 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