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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Vasoconstriction (2126); Embolism/Embolus (4438)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device: 30927997l number, and no internal action related to the complaint was found during the review.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) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac arrest and arterial spasm requiring prolonged hospitalization.It was reported that after the procedure, there was pericardial effusion (pe) confirmed on the body surface echography.Electrocardiogram showed st elevation, and coronary artery spasm was also confirmed.After extubating by the anesthesiology department, both blood pressure and spo2 became unmeasurable, and cardiac arrest was confirmed because the heart was not beating when fluoroscopy was performed.Initial waveform pea.Timing when complaints occurred was 30 minutes after the procedure, after extubating.Resuscitation was performed, and rosc (return of spontaneous circulation).Spontaneous breathing and eye opening were observed.The patient is being follow-up.Atrial septal puncture was performed.Ablation was performed before pericardial effusion was identified.There was no evidence of steam pop.Irrigation catheter¿s flow rate setting: stsf was used, and the flow rate was set as specified.There were no abnormalities observed prior to and during use of the product.Extended hospitalization was required.The physician provided the correct information that ¿no pericardial effusion was observed with the surface echography in which performing by routine after the procedure¿.The st elevation and cardiac arrest occurred with awakening from anesthesia.Coronary angiography after the introduction of pcps showed coronary spasm, so coronary artery was dilated using a vasodilator, and then autologous pulse was resumed.The adverse event occurred on (b)(6) 2023.It was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that there was no perforation by catheter.It was unknown whether the coronary spasm was due to ablation or not.Patient required extended hospitalization because of the adverse event.Other relevant history --- interstitial pneumonia, ef 30%, rheumatoid arthritis.Force visualization features used were real time graph; dashboard; vector.Additional filter used with the visitag was fot.Tag index was used.Transseptal puncture was performed.Stsf was used, and the flow rate was set as specified.

Manufacturer Narrative

Additional information was received on 30-mar-2023.It was reported that the physician considered that the adverse event occurred due to the patient condition but the actual cause was unknown.The intervention provided was the administration of vasodilators, heart massage, and tracheal intubation.The patient was followed-up in the intensive care unit (icu).While following up, the patient developed a cerebral embolism.We tried, but we could not obtain the information about the treatment for a cerebral embolism.The patient was still in the hospital and the condition was improving.Since the patient developed a cerebral embolism, the patient was going to be transferred to a rehabilitation hospital.The h6.Health effect - clinical code was updated and code embolism/embolus (e0503) was added.A smartablate generator was used.A visitag module was used and the parameters for stability were 3mm, 3sec.A radiofrequency (rf) needle was used.The correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.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: 16637128
• MDR Text Key: 312237058
• Report Number: 2029046-2023-00671
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30927997L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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: UNK BRAND TRANSSEPTAL NEEDLE.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 76 KG