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

Catalog Number D134804

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 5/1/2018.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.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.Manufacturer ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a thermocool® smart touch® sf bi-directional navigation catheter, and high force values were observed.After re-zeroing, the force value stayed on high even after removing the catheter out of the body.The cable was replaced with no resolution.The catheter was then replaced, and the issue resolved without patient consequence.The (b)(6) 2018 failure analysis lab (fal) findings of liquid found inside clear pebax sleeve.No visual damages found.The issue of high force value and liquid in the pebax sleeve is not reportable.The potential that it could cause or contribute to a death or serious injury is remote.Therefore, this event was initially assessed as not reportable.This event is being reported because the bwi failure analysis lab received the device on for evaluation and the (b)(6) 2018 fal findings from the scanning electron microscope (sem) showed evidence of mechanical damage, stress marks, and a hole on the surface of the pebax.A hole in the pebax is a reportable issue.This complaint has been assessed as reportable.The awareness date was reset to (b)(6) 2018.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a thermocool® smart touch® sf bi-directional navigation catheter, and high force values were observed.The device was visually inspected and some liquid was found inside the pebax.No visible damage was observed.The magnetic sensor functionality was tested on carto and the catheter failed.Error 105 and 106 were 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, 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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the internal failure of the sensor cannot be determined.The customer complaint was confirmed.The root cause of the internal failure of the sensor cannot be determined, however, an internal corrective action was created to investigate this issue.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 ref no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-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: 7664503
• MDR Text Key: 113310096
• Report Number: 2029046-2018-01768
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2018
• Device Catalogue Number: D134804
• Device Lot Number: 17755293L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1