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

Model Number D-1336-04IL-S

Device Problems Cut In Material (2454); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that smarttouch thermocool catheter could not deflect during the procedure.Upon receiving, the catheter was visually inspected and it was found that tip lumen had a metal exposed.An x-ray image was taken from the area and it was noticed that the t bar was slid down getting caught and exposed at tip lumen.This condition may contribute due to the fact that the t-bar is applying stress at that point.Per the event reported the catheter was tested for deflection and the catheter failed due to the t bar was slid down from their place.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 customer complaint has been verified.A corrective action was created to address the t bar issue.

Event Description

This complaint is originally reported for deflection issue and assessed as not mdr reportable.The device appeared in normal conditions when it was received for initial analysis in bwi failure analysis lab in (b)(4) on 09/16/2015.However bwi failure analysis lab in (b)(4) found mdr reportable findings on (b)(6) 2015 that the device had the t-bar cut through the surface of the shaft and the metal (t-bar) was exposed.This occurred during transit between bwi labs and bwi takes conservative approach to report this event due to loss of catheter integrity.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION 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: 5225972
• MDR Text Key: 31681197
• Report Number: 9673241-2015-00821
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2015

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: 01/31/2016
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17184505M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2015
• Initial Date FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1