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); Vasoconstriction (2126)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31079938l and no internal action related to the complaint was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with an thermocool smarttouch sf catheter.The patient experienced coronary artery spasm and cardiac arrest.The events required prolonged hospitalization and surgical intervention.After the pulmonary vein isolation (pvi), the cavotricuspid ishmus (cti) line was checked and when mapping was started, and it was noted that the patient's blood pressure dropped.The patient's heart stopped once, but recovered by medical intervention.However, the patient had ventricle tachycardia, and cardiac massage was performed.Patient required extended hospitalization after the event.The adverse event was discovered during use of biosense webster products.An air embolism was initially suspected, however, the physician stated that they believed the cause was coronary artery spasm (on all three branches) induced by precedex.Intervention provided was put on ecmo (extra corporeal membrane oxygenation) and impella, measures which were removed on (b)(6) 2023.The patient was intubated as well.This adverse event is being captured on the ablation catheter as ablation did occur prior to noting the adverse event.The air embolism was not the cause of this adverse event and instead coronary spasms were the cause, as described by the physician.The air embolism was just suspected and never confirmed, while the coronary spasms were confirmed via coronary angiography.

Manufacturer Narrative

On 16-oct-2023, bwi received additional information indicating that the sheath used at the time of the adverse event was a agilis s curve, swartz 8.5fr slo sheath.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: 17918090
• MDR Text Key: 325444667
• Report Number: 2029046-2023-02295
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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 Expiration Date: 06/30/2023
• Device Catalogue Number: D134805
• Device Lot Number: 31079938L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• 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: AGILIS S CURVE, SWARTZ 8.5FR SLO SHEATH.; CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; IMPELLA HEART PUMP.; NRG TRANSSEPTAL (RF) NEEDLE.; SOUNDSTAR CATHETER.; UNSPECIFIED GENERATOR.; UNSPECIFIED PUMP.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG