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 Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Scratched Material (3020)

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

Event Date 09/10/2014

Event Type  malfunction  

Event Description

It was reported that while performing an atrial fibrillation procedure with a smarttouch bidirectional catheter, the complaint device was said to have experienced non-mdr reportable deflection issues.The procedure was completed with no patient consequence.The bwi failure analysis lab (fal) received the device for evaluation and discovered that a sharp internal metal component, the t-bar, was exposed through a bump found on the lumen of the device.Due to the compromised integrity of this catheter, exposed metal, this event is mdr reportable.The awareness date was reset to (b)(4) 2014 for this complaint, the date of the fal lab discovery.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: unk.(b)(4).The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.

Manufacturer Narrative

(b)(4) it was reported that while performing an atrial fibrillation procedure with a smarttouch bidirectional catheter, the complaint device was said to have experienced non-mdr reportable deflection issues.The bwi failure analysis lab (fal) received the device for evaluation and discovered that an internal metal component, the t-bar, was exposed through a bump found on the lumen of the device.Due to the compromised integrity of this catheter, exposed metal, this event is mdr reportable.The awareness date was reset to 12/4/2014 for this complaint, the date of the fal lab discovery.Upon receiving, the catheter was visually inspected and it was found that the tip lumen material had white stress marks and that the t-bar metal was exposed through a bump in the material.Per these conditions, an x-ray image was taken of the area and it was noticed that the t bar had slid down out of place.One of the t bars was caught at the tip lumen and was exposed.Per the event reported, the catheter was tested for deflection and the catheter failed due to the t bars which had slid down from their place.The customer complaint has been verified.An internal correction has been opened to address the t bar 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.

• 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 highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4370807
• MDR Text Key: 5235262
• Report Number: 9673241-2014-00634
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 09/16/2014

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: 02/27/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 16072615M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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