MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408646

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/29/2019

Event Type  Injury  

Event Description

When the catheter was pulled out of the patient there was a blood clot present on the catheter, and was unable to be purged from the catheter.Another catheter was used to continue and complete the procedure.

Manufacturer Narrative

One dragonfly optis catheter was returned to the manufacturer for analysis.The results of the investigation were inconclusive due to the condition of the returned device.There was dried contrast and blood-like substance inside the catheter lumen which was unable to be purged.The catheter was submerged in an ultrasonic water bath to remove the dried contrast; however, the dried contrast was still unable to be removed and purged, which prevented further functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported event remains unknown.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9309736
• MDR Text Key: 168228067
• Report Number: 3008452825-2019-00570
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: C408646
• Device Lot Number: 7094641
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other