MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-01-S

Device Problem Low impedance (2285)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/16/2014

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6), male, underwent an atrial fibrillation (afib) procedure suffered cardiac tamponade.The impedance was displayed 190-200 ohm when the smart touch catheter was inserted into the cardiac cavity.The impedance was displayed around 170 even when the catheter was not in contact with a cardiac wall.The indifferent electrode was reattached, the cable for of the catheter changed but the issue continued.Finally, the catheter was changed and the impedance was slightly decreased then the ablation with 30w was started.In addition, a big noise began at the catheter.The noise was improved when the cable was changed.Just after the procedure, the blood pressure dropped and pericardial effusions was confirmed.Cardiac drainage was conducted and then the patient was stable.The physician commented that cause of the tamponade was unknown, but the event might occur due to several times dc shock or touching to the cardiac muscle by the catheter.

Manufacturer Narrative

(b)(4).Concomitant medical products: c3 interface cable ¿ therapeutic, model # d-1286-03-s, lot # 15766921l; carto 3, model# fg-5400-00m, serial # (b)(4).(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: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 4241996
• MDR Text Key: 5012812
• Report Number: 9673241-2014-00470
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• 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: 03/31/2015
• Device Model Number: D-1327-01-S
• Device Catalogue Number: D132701
• Device Lot Number: 16102077M
• Other Device ID Number: (01)10846835009163
• 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: 04/13/2014
• 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
• Patient Age: 65 YR