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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-sep-2023.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 receiving cardiac ablation procedure involving a thermocool® smart touch® sf bi-directional navigation catheter experienced cardiac arrest requiring medical intervention.It was reported that an invalid temperature reading was being displayed on the smartablate generator.The ablation cable was replaced without resolution.The ablation catheter (lot #: 31100155l) was replaced with ablation catheter (lot #: 31095990l) and the issue resolved.The procedure continued.The caller stated that later on during the procedure, after 45 minutes of ablation, the patient's blood pressure dropped.The patient went into "cardiogenic shock from fluid overload".The physician then called the cardiac arrest code.A swan catheter was placed into the patient¿s right side of the heart and wedge pressure measurements were obtained.The physician then placed an impella device into the patient's heart.The caller stated that a bwi ultrasound catheter, a bwi vizigo sheath, a bwi deca nav, and a bwi thermocool® smart touch® sf bi-directional navigation catheter (lot #: 31095990l) were in use when the event occurred.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review, noted a correction to the 3500a follow-up #1.It should have included in the h10.Additional manufacturer narrative: biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2023-02334 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter ¿ reportable event: malfunction).Mfr # 2029046-2023-02097 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter ¿ reportable event: serious injury).

Manufacturer Narrative

It was reported that a patient receiving cardiac ablation procedure involving a thermocool® smart touch® sf bi-directional navigation catheter experienced cardiac arrest requiring medical intervention.The investigation was completed on 19-sep-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 17761187
• MDR Text Key: 323576641
• Report Number: 2029046-2023-02097
• 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,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31095990L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/16/2023; 10/16/2023
• Supplement Dates FDA Received: 10/16/2023; 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; 8.5F SHEATH WITH CURVE VIZ LGC; BWI ULTRASOUND CATHETER; IMPELLA DEVICE; SWAN CATHETER; THMCL SMTCH SF BID, TC, D-F; UNK ABLATION CABLE; UNK ABLATION CABLE; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening