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 Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

It was reported that after few hours into an atrial fibrillation (afib) procedure, the catheter could not deflect as intended.The procedure was completed using a same like device without any patient consequences.This initial complaint was not reportable event.Upon visual inspection of the returned complaint catheter on march 10, 2015 it was found that the t bar was exposed through the shaft at 2.3 cm from the catheter tip dome.Biosense webster has thus assessed this event as reportable with march 10, 2015 as the new alert date for this report.

Manufacturer Narrative

(b)(4).An x-ray of the catheter was taken and it was noticed that one of the t bars slid down crossing the catheter lumen and got exposed.During manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent damage peek housing/tip from leaving the facility.A corrective action has been opened to address and resolve this issue.Due to one of the t bars was out of place, deflection test failed, concluding that the t-bar is the root cause of the deflection issue reported by the customer.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 reported customer complaint has been verified.

• 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 hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4643435
• MDR Text Key: 5595609
• Report Number: 9673241-2015-00175
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17079133M
• Other Device ID Number: (01)10846835009200
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1