MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID; CATHETER, ELECTRODE RECORDING

Model Number D-1079-259-S

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); ST Segment Elevation (2059); Brain Injury (2219)

Event Date 12/17/2013

Event Type  Injury  

Event Description

It was reported minutes after the transseptal puncture was performed during the atrial fibrillation (afib) procedure, there was an elevation of the st wave on the ecg.It was thought that air was introduced inside the patient through the agilis sheath from st.Jude medical and an air embolism was produced.The patient was treated with urgency.Upon request, additional information was provided on the event.The patients¿ health status baseline before the procedure was that he was stable and in sinus rhythm.The event was life threatening.During the sheath manipulation, they observed an elevation of the st wave in the ecg.They probably introduced air accidently inside the patient.The patient was treated to remove the air by a hemodynamic physician and was in observation after the procedure.The patient required extended hospitalization and suffered permanent brain damage.

Manufacturer Narrative

Concomitant products: c3 external reference patch, model #: d-1283-02, lot #: ll082613.(b)(4).

Manufacturer Narrative

This supplemental report is to correct the statement that was previously reported in the initial report which stated that the device evaluation was anticipated but had not yet begun.The product was discarded.Therefore, since the device will not be returned to biosense webster for analysis, no further investigation can be performed at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record review could be performed.(b)(4).

• Brand Name: WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3563106
• MDR Text Key: 4057728
• Report Number: 2029046-2014-00007
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1079-259-S
• Device Catalogue Number: D6DR252CT
• Device Lot Number: UNKNOWN_D-1079-259-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 61 YR