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

Catalog Number D134804

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected and ring 1 was found raised up and sharp on the tip dome.Then, during the second visual inspection, the ring was not observed lifted, however, a foreign particle was observed underneath the ring.The magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Force feature was unable to test since a temperature issue was observed.Then, an electrical test was performed on the catheter and it was found within specifications, however, the thermocouple values were found out of spec.A failure analysis was performed and it was found that there is an electrical intermittence on the tip area creating the temperature issue.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is primarily composed of a polyethylene-based material.However, the source of origin remained unknown.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 was confirmed.The root cause of the particle underneath the ring cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device, however, this cannot be conclusively determined.In addition, temperature failure is detectable in production, however, the wires can break during the procedure due to the manipulation of the device.This failure does not represent any patient safety impact.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a temperature issue occurred.It was reported that after a few minutes after working with the thermocool® smart touch® sf bi-directional navigation catheter, a ¿no temperature¿ error message was displayed.The cable was replaced without resolution.Thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The case continued and finished successfully.There was no patient consequence.The reported ¿no temperature¿ issue is not mdr reportable since the potential that it can cause or contribute to a death or serious injury or other significant adverse event is remote.On12/7/2018, the thermocool® smart touch® sf bi-directional navigation catheter was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.On 1/8/2019, a visual analysis was performed under a microscope and revealed no lifted conditions were found on the electrode ring, however, a foreign particle was noticed underneath the electrode ring.Additionally, on 1/15/2019, a fourier transform infrared spectroscopy (ftir) analysis was performed.The ftir overall concluded the white particle is primarily composed of a polyethylene-based material.The source of origin remained unknown.This issue of foreign material has been assessed as mdr reportable.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 01/08/2019 and has reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS
• 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: 8306941
• MDR Text Key: 137023338
• Report Number: 2029046-2019-02640
• 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
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: D134804
• Device Lot Number: 30088100L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• 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