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

Model Number 1014651

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 12/27/2021

Event Type  malfunction  

Event Description

During the procedure, when the catheter was inserted into the guiding catheter, blood was noted to be coming back and a hole in the catheter was suspected.Another catheter was used to complete the procedure with no adverse patient consequences.

Manufacturer Narrative

One dragonfly opstar imaging catheter was received for evaluation.The results of the investigation concluded that liquid came out of the purge hole as expected during the purge test; no liquid leaked out of any other catheter location.Dimensional inspection revealed the purge hole diameter met the specifications.There were no damages or anomalies noted with the returned catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the condition of the returned device and the information received from the field, the cause of the reported event remains unknown.

• 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: 13232613
• MDR Text Key: 287330494
• Report Number: 3009600098-2022-00002
• 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,Followup
• Report Date: 03/08/2022

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 Expiration Date: 10/09/2023
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8157516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2021
• 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