MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD DRAGONFLY OPTIS KIT BOX IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408646

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

One dragonfly optis imaging catheter was received for evaluation.A hoop and the syringe were also returned.The results of the investigation confirmed that the returned catheter was able to be purged as normal, after the dried contrast was removed via water bath, with no air bubbles, leaks, or anomalies noted.Dimensional inspection revealed the purge hole diameter also met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the returned condition of the device and the information received, the cause of the reported event remains unknown.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

When the catheter was purged, air bubbles were noted in the side port.The bubbles were attempted to be aspirated and elevations were noticed in the ecg.The device was removed and the procedure was completed without oct.Oxygen was administered and the elevations disappeared after a few minutes.

• Brand Name: DRAGONFLY OPTIS KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9799370
• MDR Text Key: 188862169
• Report Number: 3009600098-2020-00004
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 7178915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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
• Patient Outcome(s): Required Intervention