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

Model Number D132705

Device Problems Signal Artifact/Noise (1036); Insufficient Cooling (1130); Electrical Shorting (2926)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

The event date is unknown.Therefore, the first day of the year has been entered as the date of event.The bwi product analysis lab received the device for evaluation on 03-aug-2022.The device evaluation was complete on 01-sep-2022.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and functional test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material on the thmcl smrttch device.Microscope examination in the pebax area revealed that there is a hole in the pebax.An electrical test was performed and no electrical issues were found.Temperature and impedance and cool flow tests were performed and the device was found working correctly.No temperature, impedance, or irrigation issues were observed.The device was connected to the carto 3 system and the device was visualized and recognized correctly; however, the force vector was not visualized since error 105 ¿magnetic catheter sensor error¿ appeared on the carto 3 screen.The catheter was dissected, and it was found that the tip lost the sensor wire continuity.The root cause of the damage on the pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.However, it could be related to the handling of the device during the procedure, but this cannot be conclusively determined.The event described was unable to be duplicated during the product investigation.However, the blood inside the pebax area found could be related to the reported issue.It should be noted that product failure is multifactorial.Regarding the additional finding observed, the instruction for use contains the following information: -ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.- the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.-if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed and no internal actions related to the complaint were found during the review.(b)(4).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole in the pebax.Initially it was reported that after several ablations without issue, a current leakage issue occurred.Body surface (bs) ecg disappeared from the system.Ngen shows catheter temp of 84 deg.The catheter was removed and all cables disconnected.Reconnected system.No issues when reconnecting cables.On introducing the thermocool® smart touch¿ bi-directional navigation catheter, bs ecg disappeared again.Cable was swapped and same issue.Catheter was swapped and it resolved the issue.The procedure was prolonged by 10 minutes.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The high temperature issue was assessed as not mdr reportable.Since there is no information stating that the user-defined cut-off was exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The current leakage issue was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The signal issue was assessed as not mdr reportable.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 01-sep-2022 there was reddish material and a hole in the pebax.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 01-sep-2022.

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15453444
• MDR Text Key: 306418758
• Report Number: 2029046-2022-02271
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2023
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30717316M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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: UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNK_NGEN RF GENERATOR