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

Model Number D134804

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a thermocool® smart touch® sf bi-directional navigation catheter (stsf).There were issue with hemostatic valve leak and a bad/no ecg signal on all channels.It was initially reported that with the vizigo¿ sheath, a hemostatic valve problem occurred.For the ablation catheter (stsf), a problem with ecg, when connected, the ecg disappears.There were no patient consequences.Additional information reports that the problem with the hemostatic valve was that the ablation catheter and pentaray were not passing.Valve was not noted to be dislodged in any capacity.Brim cap/hub was not detached.Sheath was being used on the patient but no air entered the body.Blood return was observed and the approximate volume of blood lost was "normal".Ecg signal disappeared on all channels.Interference was observed on all systems.The physician did not have any intact ecg signal available to monitor patient heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.The obstructed sheath issue is not mdr reportable to the us fda.The hemostatic valve leak issue is mdr reportable to the us fda.The bad/no ecg all channels (bs and ic) is mdr reportable to the us fda.

Manufacturer Narrative

Date of event: the event date is unknown.As a result, the first day of the year has been entered as the event date.Initial reporter phone: (b)(6).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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-00326 for product code d138501 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).(2) mfr # 2029046-2023-00327 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

Additional information was received on 28-feb-2023.It was reported that a cable was used and the lot number of 30924114l was provided.Therefore, the concomitant product section was updated.It was also reported that ¿there was a problem with the connection, the ecg gave an error¿.Further clarification is needed regarding the additional information received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number pc-001279349 has two reports: (1) mfr # 2029046-2023-00326 for product code d138501 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium); (2) mfr # 2029046-2023-00327 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

Additional information was received on 14-apr-2023.Clarification was requested on what the ecg error was, and the response was that the error message is unknown (cannot be recalled) and when connection was made, the ecg disappeared.It was also noted that to resolve the issue, the catheter was replaced.Therefore, the concomitant product section was updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-00326 for product code d138501 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium), (2) mfr # 2029046-2023-00327 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

On 14-jul-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-00326 for product code d138501 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).(2) mfr # 2029046-2023-00327 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).

• 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: 16400610
• MDR Text Key: 310209196
• Report Number: 2029046-2023-00327
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030031
• 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,Followup,Followup,Followup
• Report Date: 08/10/2023

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: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/28/2023; 04/14/2023; 07/14/2023
• Supplement Dates FDA Received: 03/28/2023; 05/11/2023; 08/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; CBL,12HYP/12 REDEL,YELLOW,10'; THMCL SMTCH SF BID, TC, F-J; UNK_PENTARAY