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

Catalog Number D134805

Device Problems Signal Artifact/Noise (1036); Hole In Material (1293); High Sensing Threshold (2574); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the returned device was visually inspected and reddish material was found inside the pebax, however, no damage was observed.Additionally, a whitish foreign material was found under electrode # 2; electrode # 2 was found scratched and lifted.The catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was evaluated for screening test and catheter passed.The force feature was working properly.Finally, the force sensor values were found within specifications.Then, the catheter was tested for electrical performance and it was found within specifications.The catheter's outer diameter was measured and it was found within specifications.Per the condition observed, the catheter outer diameter was measured and it was found within specifications.Per the foreign material observed, a fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the foreign material is presumable composed of polyethylene with barium sulfate.Additionally, per the damage observed a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage and a hole on the surface of the pebax.Ring showed evidence of mechanical damage and scratches but no sharp edges were found.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 cannot be confirmed.Based on available analysis finding results, the damage observed does not appear to be caused by any internal bwi processes since there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter.After connecting the thermocool® smart touch® sf bi-directional navigation catheter to carto 3 system, the catheter was zeroing when the distal electrode signal of the catheter was zero.The force value was reported to be too high and subsequently an error message of ¿(106) force catheter sensor error¿ was displayed.First, zeroing was done again.Second, the map cable connected to the catheter was checked to check if it was a problem with the cable.Third, the piu was rebooted for checking the recognition problem.However, the event continued.Finally, the customer replaced the catheter to a new one and then error message was gone.The force value was at normal range.The issue of force high is not a reportable issue, and the issue of error message displayed is not a reportable issue since warning functioned as intended.No patient consequences were reported.On 02/27/2018, the thermocool® smart touch® sf bi-directional navigation catheter was returned to biosense webster inc.¿s (bwi) failure analysis lab (fal) for evaluation.Visual and functional analysis revealed a reddish material was found under the pebax and whitish foreign material was found under electrode # 2.No other physical damage was found on the catheter.On (b)(6) 2018, further testing was performed including an scanning electron microscope (sem).The sem results showed evidence of mechanical damage and a hole on the surface of the pebax.Ring showed evidence of mechanical damage and scratches but no sharp edges were found.The whitish foreign material found on electrode # 2 is considered to be a reportable malfunction.The issue of a "hole" on the pebax is also considered a reportable malfunction.As such, the earliest awareness date of these finding is 2/27/2018.

• 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: 7379106
• MDR Text Key: 104037830
• Report Number: 2029046-2018-01360
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/27/2018

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: 09/28/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17740162L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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