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

Model Number D134805

Device Problems Insufficient Cooling (1130); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and an internal components exposed issue occurred.It was reported that there was a high temperature error message on the smartablate generator, and they were unable to come on for ablation.The stsf catheter was removed from the body, and it was noticed that the catheter was physically damaged.The bwi representative reported that it appeared that the stsf catheter may have been torqued too hard, as there was a noticeable break in the insulation about three inches of the way down from the tip.The internal wires were exposed.The stsf catheter was replaced, and the issue resolved, and the procedure continued.No adverse patient consequence was reported.Additional information was received on 20-feb-2023.It was reported that there were no lifted nor sharp rings from the damaged catheter.The catheter was easily removed from the sheath and was inserted easily.The damage was three inches from the catheter tip.The catheter was not pre shaped in any way.The high temperature cut-off exceeded (ablation stopped) issue was assessed as not mdr reportable.The internal components exposed issue is mdr reportable to the fda.

Manufacturer Narrative

The device evaluation was completed on 03-apr-2023.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and an internal components exposed issue occurred.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, a cool flow pump and pressure gage, and a temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed that the tip was partially detached from the shaft and the internal components were exposed.A temperature and impedance test were performed, and the device was found to be working properly; however, a cool flow and pressure gage test was performed, and it was observed that there was a leakage where the tip was found detached.This failure could be related to the high temperature issue reported.This unit was inspected prior to leaving the facility as there are functional tests and inspections based on the corresponding process flow diagram (pfd).A manufacturing record evaluation was performed for the finished device 30935079l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.The root cause of the partially detached tip could be related to the wrong manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use contain the following recommendations stated in the carto 3 system manual: -always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the catheter.-do not manually pre-shape the distal shaft of the catheter by applying external forces intended to bend or affect the intended shape or curve of the catheter.-do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16560127
• MDR Text Key: 311593058
• Report Number: 2029046-2023-00563
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30935079L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2022
• 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
• Treatment: THMCL SMTCH SF BID, TC, D-F.; UNK ST JUDE AGILIS 8.5FR SHEATH.