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

Catalog Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device was visually inspected and foreign material was found on the tip, blocking some irrigation holes.Irrigation testing was performed and the catheter failed due to the material observed.Electrical testing was performed and the catheter failed.No electrical readings were observed on electrode # 1.A failure analysis was performed and the catheter was dissected on the tip area.The electrical wire was found broken causing the improper electrical signal.The catheter was connected to the stockert generator and the temperature values were observed correctly.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material was composed of silicone based material.Silicone is widely used on medical devises and procedures.However, the source of origin remains 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.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 foreign material on the dome cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Concomitant products: stockert generator (model# unknown serial# unknown).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter, and a high temperature reading was observed.During pulmonary vein isolation (pvi) ablation the temperature displayed over 40c.The cable was reconnected and the issue did not resolve.Therefore, the catheter was removed from the patient and flushing was performed, but the issue did not improve.The catheter was then replaced and the issue resolved.The procedure was completed without patient consequence.Settings during the event include the generator being set in power control mode.No system errors were observed.The system stopped ablation once cut off values were exceeded.This was originally assessed as not reportable because the potential that it could cause or contribute to death, serious injury, or other significant adverse event is remote.The device was returned to the bwi failure analysis lab (fal) and on 5/25/2018 it was discovered that the tip had foreign material and was blocking some irrigation holes.In addition on 6/6/2018 the qa analytical laboratory results showed that the foreign material was composed of silicone based material.The finding of foreign material has been assessed as reportable.

• 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: 7626708
• MDR Text Key: 112499064
• Report Number: 2029046-2018-01720
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

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: 05/31/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17680234L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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