MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1292-05-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/16/2014

Event Type  Injury  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, pace map was conducted and the abnormal conduction pathway was identified after performing the voltage mapping.Then, ablation was started the abnormal conduction pathway and low voltage area longitudinally.When the ablation line was almost completed, the patient's blood pressure dropped effusion was observed by the echo then a heparin administration was stopped.Pericardial drainage was performed.The patient's consciousness was clearly from beginning to end and condition was stable after drainage.The physician commented that the cause of the event might have occurred due to picking the cardiac muscle by a catheter during mapping phase or ablation phase.In addition, the cardiac muscle became thin due to the omi (old myocardial infarction).Multiple attempts were done to request for further details of the event.However, no additional information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical product: carto xp, model# m-4700-01, serial # unknown.(b)(4).

Manufacturer Narrative

The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4241994
• MDR Text Key: 5012811
• Report Number: 9673241-2014-00469
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 16106818M
• Other Device ID Number: (01)10846835003338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2014
• 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