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 Break (1069); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the catheter was recognized by the carto 3 system, no error messages were displayed and the catheter was properly visualized.The catheter was evaluated for screening test and force calibration check and catheter passed both tests.The force feature was working properly; the force sensor values were found within specifications.The catheter was evaluated for the functionality of the magnetic sensor and one of the magnetic coils failed.Further investigation revealed that the root cause was an internal failure of the sensor at the tip area.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 blood at catheter tip has been confirmed.Based on available analysis results cannot be identified whether the issue is related to an internal or an external cause.Customer complaint regarding a force issue was unable to be confirmed.Catheter failed during magnetic functionality test on carto; the root cause of magnetic sensor coil open circuit could not be determined.

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocoolsmarttouch bi-directional navigation catheter and a force issue occurred.The physician commented that the contact force value of the smarttouch catheter was displayed imprecisely during the procedure when the catheter was inserted into the cardiac cavity.Furthermore, the physician also commented that blood had flowed into the tip of the catheter near electrode #2 and #3.Additional information was received that there was no difficulty experienced while maneuvering the catheter or during the withdrawal and pebax damage was seen.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.These issues were originally assessed as not mdr reportable because the potential risk that the force issue could cause or contribute to a death or serious deterioration in the patient's state of health is remote.In addition, the additional information received does state there was pebax damage, however the extent of the damage was unknown, as well as there was no picture available for review.On september 12, 2016, the catheter was returned to the bwi failure analysis lab and during visual inspection it was discovered that there was reddish brown material found under the pebax.No pebax damage was noted at this time.On (b)(6) 2016, after further analysis, the bwi failure analysis lab discovered that the pebax was broken as a hole was observed on the pebax.This finding has been assessed as mdr reportable because there is a risk to the patient such as contamination or internal parts being exposed that could cause issues such as thrombus.This event was assessed as not reportable until it was confirmed that there was damage in which there was a risk to the patient.The awareness date has been reset to (b)(6) 2016, the date the reportable damage was discovered.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6067271
• MDR Text Key: 59228048
• Report Number: 9673241-2016-00749
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)160408(17)170331(10)17445791M
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17445791M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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