MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1347-02-S

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Thrombosis (2100); Stenosis (2263)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

The ¿suspected medical device¿ reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool smart touch bi-directional navigation catheter approved under p030031/s053.(b)(4) are related to the same incident.Upon receipt, the catheter was visually inspected and it was found in normal conditions.The returned device was then evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section creating an intermittence of temperature.An internal corrective action was created to address this issue.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.The catheter failed during thermocouple test however this condition is not related to the thrombosis and pulmonary vein stenosis.The root cause of the thermocouple breakage could not be determined.

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a thermocool smarttouch sf uni-directional nav catheter and suffered pulmonary vein stenosis and thrombosis.There was a loss of display of the temperature value.The catheter was replaced and the issue resolved.The procedure was completed without patient consequence.This event was originally assessed as not mdr reportable because the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Post-procedure, the patient returned to the hospital on (b)(6) 2016 with dyspnea and chest pain associated with breathing.An angiography revealed left inferior pulmonary vein preostial stenosis and left superior pulmonary vein thrombosis.The patient's condition is now better despite an adverse event related to anticoagulation.There is no further information about any additional intervention performed.The patient left the hospital on (b)(6) 2016.The physician did not provide causality opinion for the event.The awareness date for this record is february 17, 2016 because that is when the patient update information was received.

Manufacturer Narrative

Additional testing was performed on the catheter after the initial 3500a report with the product analysis was sent.(b)(4) it was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a thermocool smarttouch sf uni-directional nav catheter and suffered pulmonary vein stenosis and thrombosis.The returned device was visually and it was found in normal conditions.An irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The returned device was then evaluated for electrical resistance and thermocouple test.Catheter failed during thermocouple test.Further examination revealed that the thermocouple wires were broken at the tip section.Per this condition force feature cannot be verified; however the catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.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.Catheter failed during thermocouple test; however this condition is not related to the pulmonary vein stenosis and thrombosis later reported.The root cause of the outcome presented on the patient remains unknown.An internal corrective action was created to address tc breakage on the tip section for st and st sf catheters.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5488176
• MDR Text Key: 39936444
• Report Number: 9673241-2016-00177
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: D-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17175080L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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
• Patient Age: 52 YR