MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL POINT¿ IRRIGATION PUMP TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	85785
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, an air embolism occurred.The saline bag became empty while in the left atrium and while switching the bag, the operator inadvertently adjusted the valve so air was flushed into the left atrium.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported air embolism was due to user error.Per the ifu, do not prime the catheter while it is in the patient.
Event or Problem Description
During the procedure, an air embolism occurred.The saline bag became empty while in the left atrium and while switching the bag, the operator adjusted the valve incorrectly and air was flushed into the left atrium.Cpr, epinephrine, and nitro were administered to the patient.The patient is currently in stable condition with a prolonged qt interval.A ct scan revealed no anomalies.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Additionally, no batch number was provided so the device history record was unable to be reviewed.Based on the information received, the cause of the reported air embolism was due to user error.

• Brand Name: COOL POINT¿ IRRIGATION PUMP TUBING SET
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 7672966
• Report Number: 2030404-2018-00049
• Device Sequence Number: 11144933
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: 85785
• Device Catalogue Number: 85785
• Device Lot Number: 4892640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 07/18/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 07/18/2018; 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 72