THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

Report

• Report Number: 9673241-2016-00690
• Event Type: Malfunction
• Date Received: October 12, 2016
• Date of Event: September 15, 2016
• Report Date: September 15, 2016
• Manufacturer: BIOSENSE WEBSTER, INC. (JUAREZ)
• Product Code: LPB
• UDI-DI: 10846835009194
• PMA / PMN Number: P030031/S053
• Removal / Correction Number: NA
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. CONCOMITANT PRODUCTS: BAYLIS TORFLEX 8.5FR TRANSSEPTAL GUIDING SHEATH. DAIG SHORT HEMOSTASIS 8FR FAST CATH SHEATH. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER WHERE THE PLASTIC LOCATED AT THE CATHETER TIP BECAME PARTIALLY SEPARATED, CREATING BUBBLE OVER THE TIP. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND A LIGHT OFF-WHITE FOREIGN MATERIAL WAS FOUND COVERING THE TIP DOME AREA. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) WAS PERFORMED IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL. THE RESULTS DEMONSTRATED THAT THE MATERIAL WAS OF A BIOLOGICAL (HUMAN) ORIGIN. BASED ON THIS, IT CAN BE DETERMINED THAT THE MATERIAL DOES NOT BELONG TO THE CATHETER, AND ITS PRESENCE COULD BE A RESULT OF THE PROCEDURE. THE CATHETER WAS INSPECTED, AND THE TIP WAS FOUND IN GOOD CONDITION. NO TIP SEPARATION, BUBBLES OR OTHER DAMAGE WAS OBSERVED. ALL RINGS WERE FREE OF DAMAGE. NO BENDS OR SHARP EDGES WERE OBSERVED. THE CATHETER OUTER DIAMETERS WERE MEASURED AND WERE FOUND WITHIN SPECIFICATIONS. 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 REGARDING PLASTIC SEPARATION NEAR THE TIP OF THE CATHETER CANNOT BE CONFIRMED. HOWEVER, BIOLOGICAL MATERIAL WAS FOUND ON THE TIP OF THE CATHETER. THE CATHETER WAS FOUND WITHIN SPECIFICATIONS. BASED ON THE AVAILABLE ANALYSIS FINDING RESULTS, THE FAILURE MODE DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BWI PROCESSES.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER WHERE THE CATHETER TIP BECAME PARTIALLY SEPARATED. TOWARDS THE END OF THE CASE, IT WAS NOTED THAT THE TIP OF THE CATHETER HAD BECOME PARTIALLY SEPARATED FROM THE SHAFT, CREATING A 1/2CM BUBBLE OVER THE TIP DOME. THE BUBBLE COVERED THE IRRIGATION HOLES, CAUSING THE FLUSH TO DRIP SLOWLY. THIS DID NOT RESULT IN ANY EXPOSED WIRES/BRAIDING, NOR ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE NOTED DURING INSERTION OR REMOVAL OF THE CATHETER FROM THE PATIENT. THE CATHETER WAS REPLACED, AND THE CASE CONTINUED WITHOUT ANY REPORT OF PATIENT CONSEQUENCE. PARTIAL DETACHMENT OF THE CATHETER TIP PRESENTS A CRITICAL RISK OF THROMBUS TO THE PATIENT, EITHER AS A RESULT OF EXPOSURE TO INTERNAL CATHETER COMPONENTS, OR THE RISK OF COMPLETE SEPARATION OF THE CATHETER TIP. AS A RESULT, THIS EVENT IS MDR REPORTABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
676113	THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER	CARDIAC ABLATION PERCUTANEOUS CATHETER	LPB	BIOSENSE WEBSTER, INC. (JUAREZ)	D-1327-04-S	17525077M	10846835009194

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 3

• Difficult to Flush
• Material Separation
• Partial Blockage

Source type · 1

• COMPANY REPRESENTATIVE

Type of report · 2

• Followup
• Initial submission