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

Catalog Number D134702

Device Problems Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2018

Event Type  malfunction  

Manufacturer Narrative

The product evaluation has been completed.The returned device was visually inspected and ring # 1 was found lifted with white material, and reddish material was found inside the pebax.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 106 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, scratches 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.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the white particle is primarily composed of a polyethylene based material with second compound barium sulfate-based material.This composite is widely used as radio pacifier a long medical device industries.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 damage on the electrode and the pebax cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, the root cause of the foreign material underneath the electrode could be related to the sheath used during the procedure, however, this cannot be conclusively determined.

Event Description

It was reported that a patient underwent a procedure with a thermocool smart touch sf uni-directional navigation catheter wherein a contact/force issue was encountered.It was reported the catheter could not be zeroed.(b)(6) as initial value was not available.Instead (b)(6), regardless of which position zeroing was tried.The possibility of contact with other catheters or the sheath was ruled out radiologically.It was ensured that no contact with the wall was present at the relevant instant of time.The cable as well as thermocool smart touch sf uni-directional navigation catheter were disconnected and reconnected again, to no success.Then the cable was exchanged to no avail.Even after the catheter was exchanged, the issue still persisted.There was no patient consequence.The initial report of ¿force issue¿ is not mdr reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.On (b)(6) 2018, the bwi failure analysis lab (fal) received the device for evaluation.During initial visual analysis identified ¿ring #1 was found lifted with white material and damage under the pebax with reddish brown material inside.¿ the issues of physical damage to electrode rings and foreign material present in the rings have been assessed and are considered mdr reportable product malfunctions.On (b)(6) 2018, further testing which included a scanning electron microscope (sem) analysis, it was discovered that ¿sem showed evidence of mechanical damage, stress marks, scratches and a hole on the surface of the pebax.¿ this issue of physical damage ¿hole on the pebax¿ has also been assessed and considered an mdr reportable product malfunction.

• 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: 7985506
• MDR Text Key: 126104099
• Report Number: 2029046-2018-02187
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• 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: 09/20/2018

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: 03/22/2019
• Device Catalogue Number: D134702
• Device Lot Number: 30030785L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• 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