MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-05IL-S

Device Problem Torn Material (3024)

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

Event Date 06/08/2015

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch uni-directional navigation catheter and a mapping issue occurred as the catheter could not build the model.The catheter was changed to another one and the procedure was completed with no patient consequence.This event was originally assessed as not reportable as the potential risk that it could cause or contribute to a serious injury or death is remote.Biosense webster failure analysis lab received the device for evaluation on september 3, 2015 and during visual inspection it was discovered that the pebax was torn/ripped between rings #1 and #2 exposing the helix coil on the inside.Upon request additional information was received on the returned catheter condition.There was no difficulty withdrawing the catheter from the patient that may have caused this damage.The returned catheter condition was not noticed prior to use of the catheter, upon withdrawal or prior to sending the catheter back for analysis.This finding is indicative of a reportable event because the catheter integrity is compromised.The awareness date for this record is september 3, 2015 because that is when the product was received.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and a mapping issue occurred as the catheter could not build the model.The returned device was visually inspected upon receipt and pebax was found torn and ripped with helix exposed which is why this complaint was reported to the fda.Per this condition a scanning electron microscope (sem) analysis was performed over the damaged area of the catheter and it was found that the pebax external surface presented a slit that might have been induced by an object hitting the area.An internal corrective action was created to address the damaged pebax on smart touch.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto 3 system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system, however failed during force sensor test.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.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 an impossibility to build a model cannot be confirmed.Catheter failed force sensor evaluation; the root cause of the open circuit at the sensor could not be determinate.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5107720
• MDR Text Key: 27147403
• Report Number: 9673241-2015-00681
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: D-1336-05IL-S
• Device Catalogue Number: D133605IL
• Device Lot Number: 17111058M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• 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