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 Difficult To Position (1467); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

It was reported that during an afib ¿ paroxysmal procedure, the smart touch catheter did not be deflected as intended during pv isolation.The issue was resolved by changing the catheter and the case was completed without any patient's consequence.This issue is not reportable malfunction.Upon receiving the product in biosense webster lab on (b)(6) 2015, it was noticed that tip lumen has bumps with metal exposed about 22mm from the proximal end of the tip dome, making this event reportable.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) it was reported that the smart touch catheter could not be deflected as intended during pv isolation.The returned device was visually inspected upon receipt and it was found that peek housing and tip lumen transition was cracked with reddish brown material inside the area, also there was a bump at tip with metal exposed which during an x-ray analysis it was determined that it was the t-bar which slid down and crossed the catheter lumen.It is also likely when t-bar slid down applied stress to the section and contributed to the peek housing cracked.Due to the t bar being out of place, deflection test failed.Tip dome had reddish brown material on the proximal end.Per this condition the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Therefore an irrigation test was performed and the catheter passed, no occlusion was observed.Further information received indicates that these conditions were not reported by the customer.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.The device history record (dhr) was reviewed and no anomalies were found related to this failure mode.Dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint regarding a deflection issue has been verified.In addition, a corrective action has been opened to address and resolve this 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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 15715 arrow hwy; irwindale, CA 91706 ; 9098397362
• MDR Report Key: 4670324
• MDR Text Key: 5623386
• Report Number: 9673241-2015-00201
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• 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: 17083479M
• Other Device ID Number: (01)10846835009200
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1