MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1292-05-S

Device Problems High impedance (1291); Hole In Material (1293)

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

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with an ez steer thermocool navigational 4mm catheter.The bwi failure analysis lab noted the returned product condition of the proximal side of the electrode ring #1 had a copper lead wire exposed.It was originally reported the impedance of the ez steer thermocool navigational 4mm catheter was displaying around 900ohm therefore the ablation could not be conducted when the catheter was inserted into the cardiac cavity after connecting it to the patient interface unit (piu).The cable was changed and reconnected but the issue continued.The issue was resolved by changing the catheter.The procedure was completed without patient consequence.The event was originally assessed as not reportable because the high impedance disabled the ability to ablate.Upon visual inspection of the returned complaint catheter on (b)(4) 2014, the bwi failure analysis lab noted that the proximal side of the electrode ring #1 had a copper lead wire exposed causing light green material on the electrode ring and wire.This event was originally considered non-reportable; however, bwi became aware of the returned product condition on (b)(4) 2014 and have reassessed the event as reportable.The awareness date has been reset to (b)(4) 2014.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

On the initial visual inspection when the device was returned, it was discovered that the catheter has a reddish colored lead wire that was exposed.This finding was originally assessed as reportable because an exposed wire has the potential to cause a serious injury to the patient.After complete analysis of the returned product, it was discovered that the lead wire is not exposed but just visualized.This wire is actually covered by polyurethane and the wire is part of the product design.Since the wire is not actually exposed, there is no risk to the patient and this finding has been re-assessed as not reportable as the wire is not actually exposed but visualized as part of the catheter design.(b)(4) it was reported by the customer that a patient underwent an atrial fibrillation (afib) procedure with an ez steer thermocool navigational 4mm catheter and the impedance displayed around 900ohm therefore the ablation could not be conducted when the catheter was inserted into the cardiac cavity after connecting it to the patient interface unit (piu).The returned device was visually inspected upon receipt and ring 1 proximal side had greenish material.Follow up was made with the affiliate; however, this condition was not noticed by the customer.At this time the origin of the material could not be determined since this condition was not observed by the account and it is not likely related with the manufacturing process.In addition, reddish material was also observed but it was the copper lead wire that is welded to ring 1 and it can be visualized since a portion of it has to be out of the peek housing (per catheter design).Additionally, the copper lead wire was still properly covered with polyurethane (adhesive).Then per the reported event, catheter was tested for electrical performance, stockert compatibility and thermal sensor response.The catheter failed on ring 1.Further investigation revealed that the lead wire of ring 1 was not making proper contact with the electrode itself.Nonetheless, the tip dome, which is in charge of measuring the impedance, was properly working 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 cannot be confirmed since the tip dome was properly working.

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 4263121
• MDR Text Key: 5030144
• Report Number: 9673241-2014-00501
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 16045656M
• Other Device ID Number: (01)10846835003338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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