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 Problems Crack (1135); Material Integrity Problem (2978)

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

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 10/26/15.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Device evaluation for the other catheter: upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the event, a deflection test was performed and the catheter passed.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 cannot be confirmed.

Event Description

This complaint is originally created for mdr non-reportable deflection issue under two smarttouch thermocool catheters during the same procedure.This complaint is re-assessed to mdr reportable due to failure analysis lab findings on one catheter on (b)(6) 2015 that metal was exposed on the tip lumen just below the transition area with peek housing.This is reportable as the loss of integrity of this catheter due to exposed metal poses the risk to patient.The lab also found mdr non-reportable issues that the peek housing and tip lumen transition was found cracked with reddish brown material inside the area and had small open bubbles allowing some reddish brown material inside.

Manufacturer Narrative

It was reported that the 1st smart touch catheter (lot#17263882m) could not be deflected toward the d direction during the procedure.The issue was resolved by changing the 2nd smart touch catheter.After placing to the 2nd catheter, the smart touch catheter could not be deflected as intended.The issue was resolved by changing the catheter to another one.Upon receiving, the catheter was visually inspected and a non-sharp metal was found exposed below the transition area with the peek housing.Peek housing and tip lumen transition was found cracked with reddish brown material inside the area.During an x-ray analysis it was determined that t-bar was found slid down applying stress to the tip and peek housing transition area contributing to the damages observed on the device.Due to the t bar was out of place, deflection test failed.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.Corrective actions were opened to address the t bar sliding down of its place issue and peek housing issue.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5233299
• MDR Text Key: 31791984
• Report Number: 9673241-2015-00834
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

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: 05/31/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17263882M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1