MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134701

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: 1.Thermocool® smart touch® sf uni-directional navigation catheter us catalog #: d134701 lot #: 17752367l.2.Carto 3 system us catalog #: fg540000 serial #: (b)(4).Investigation summary: the device was visually inspected and reddish material was found inside the pebax.No visual damage was observed.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 105 was observed.A failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found.It was determined that the root cause was an internal failure of the sensor.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.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.On line, functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.The root cause of the damage on the pebax cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter (lot #: 17752306l).Initially, it was reported that the thermocool® smart touch® sf uni-directional navigation catheter (lot #:17752306l) had inaccurate force.The cable was replaced with no resolution.When the catheter was replaced, it was noted that there was blood on the tip of the catheter.It was also reported that the replacement thermocool® smart touch® sf uni-directional navigation catheter¿s (lot #: 17752367l) deflection broke.This catheter was replaced and the issue resolved.In addition, the account requested that the carto 3 system be checked.Since the force is not reading accurate, they want confirmation that the issue is with the cable and not the system.The cables that are being used are reprocessed.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The biological material issue was assessed as not reportable.This does not pose any risk to the patient.The force, deflection and system performance issues were assessed as not reportable.The most likely consequence was an intraprocedural delay.The potential risk that they could cause or contribute to a serious injury or death was remote.The biosense webster failure analysis lab received the thermocool® smart touch® sf uni-directional navigation catheter (lot #: 17752306l) for evaluation.On (b)(6) 2018, it was discovered that there was blood inside the pebax.No visual damages were observed.This returned condition was assessed as not reportable.If foreign material is found underneath the pebax, however; there is no damage to the pebax integrity, then the potential that it could cause or contribute to a death or serious injury was remote.In this case, no physical damage was found in the integrity of the pebax.A scanning electron microscope (sem) was performed on (b)(6) 2018.The results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.The hole on the pebax was assessed as a reportable malfunction.The awareness date for this reportable issue is (b)(6) 2018.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7638049
• MDR Text Key: 112435809
• Report Number: 2029046-2018-01726
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Catalogue Number: D134701
• Device Lot Number: 17752306L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 05/29/2018
• Date Device Manufactured: 11/08/2017
• 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