MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1336-01-S

Device Problems Folded (2630); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a thermocool® smarttouch® uni-directional navigation catheter and experienced force issues with the catheter, because of this procedure was delayed for 30 minutes.The procedure was completed successfully.This event was originally considered non-reportable; however, the bwi failure analysis lab received the device for evaluation and found that the clear sleeve on the sensor is torn and folded over inside the clear sensor sleeve.This finding is reportable because loss of integrity on the pebax could potentially contribute to an adverse event.

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).As lot #'s: 17019246m and 16087824m were provided, the device history record(s) were reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the devices were manufactured in accordance with documented specification and procedures.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a thermocool smarttouch uni-directional navigation catheter and experienced force issues with the catheter, because of this procedure was delayed for 30 minutes.This event was originally considered non-reportable; however, the bwi failure analysis lab received the device for evaluation and found that the clear sleeve on the sensor is torn and folded over inside the clear sensor sleeve.There was also one other devices involved in this case.However, the issues reported under that catheter is not reportable.The bwi failure analysis lab received the devices for evaluation.Upon receipt, the first catheter was visually inspected and pebax was found torn and folded.This type of failures is further investigated.In the manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent damage pebax from leaving the facility.Then per the event reported the functionality of the biosensor catheter was tested on carto system.The catheter failed during carto test, error 106 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.Second catheter, was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for biosensor, carto functionality.The catheter failed during the carto test error 105 was displayed.Further examination showed that the sensor was within specifications and pc board had a short circuit.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the devices were manufactured in accordance with documented specification and procedures.The customer complaint has been verified.An internal corrective action has been opened to address the damaged pebax on smart touch and a potential pcb issues/intermittency.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: 4370548
• MDR Text Key: 5118448
• Report Number: 9673241-2014-00630
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/28/2014

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: 05/31/2015
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17019246M
• Other Device ID Number: (01)10846835008982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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