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 Problems Hole In Material (1293); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2015

Event Type  malfunction  

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¿ uni-directional navigation catheter approved under (b)(4).(b)(4).This product was received as a wrong product for (b)(4); there is no malfunction reported for it.A search was performed on the complaint system and no complaint was found with a missing device for this catheter lot number.The returned device was visually inspected and a hole was found at the pebax area.Per this condition a scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that the pebax external surface presented evidence of scratches and a pinhole induced by an unknown object.An internal corrective action was created to address pebax damages.The catheter was evaluated for eeprom, and the functionality of the force and magnetic sensor was tested on carto® 3 mapping system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by the carto® 3 mapping system; however error# 105 and 106 were displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the force and magnetic sensor.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 root cause of open circuit at the sensor could not be determined.An internal corrective action was created to address this issue.

Event Description

It was reported that a patient underwent a procedure with a thermocool smarttouch sf uni-directional nav catheter.When the catheter was returned to the biosense webster failure analysis lab for analysis, during decontamination, a hole was found in the pebax of the catheter.This finding was originally reported under medwatch 9673241-2015-00806 ((b)(4)).After the initial report was submitted to the fda, further analysis was done and it was discovered that the returned catheter did not belong to the complaint it was report under.Multiple attempts were performed to clarify the complaint in which this returned catheter belonged to, however this discrepancy was unable to be clarified.Therefore a new complaint was then created for the reportable lab finding.This finding is indicative of a reportable event due to the break in the integrity of the catheter which could pose a risk to patient.The awareness date for this record is january 13, 2016 because that is when a response was received that the catheter could not be matched to a procedure or complaint.

• 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: 5430560
• MDR Text Key: 38775876
• Report Number: 9673241-2016-00076
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: D-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17145463L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2015
• Initial Date FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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