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

Model Number D-1327-05-S

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/08/2014

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6) male, underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter and suffered a cardiac tamponade.The patient¿s medical history is unknown.The physician is reporting the ablation catheter distal tip was too rigid creating a breach in the wall of the atrium causing tamponade.Additional information was received regarding the event.The patient was stable.No medical or surgical intervention was required.The patient got out the hospital 8 days after procedure and did not require additional hospitalization for the event.The physician¿s opinion regarding the cause of this adverse event is that this is device related since the catheter was too unbending and rigid.It is unknown if the physician had difficulty maneuvering the catheter.This event occurred by the atrial gap, probably due to iterative movement of the probe between the right atrium and the left ventricle during ablation of the left superior pulmonary vein.The overall time for ablation at injury site was two hours.A transseptal puncture was performed with a st.Jude needle.Settings during the event include: generator set on 30w / temperature 42 degrees, irrigation flow setting ¿ 16ml/min and 30ml/min depending on temperature.No error messages were observed on the biosense webster equipment during the procedure.Heparin was given to maintain act at 300-350 seconds.

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record was reviewed.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: 4262712
• MDR Text Key: 5048438
• Report Number: 9673241-2014-00498
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17032088M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR