MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160902
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Vasoconstriction (2126)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, d-curve.The patient experienced coronary artery spasm, cardiac arrest and air embolism.After the pulmonary vein isolation (pvi), the cavotricuspid ishmus (cti) line was checked and when mapping was started, blood pressure dropped and heart stopped once--but recovered by medical intervention.The adverse event was discovered during use of biosense webster products; however, no causal relation was established with the event and the product usage.Possibility of air embolism was suspected as an adverse event as well.The physician¿s opinion on the cause of this adverse event was coronary artery spasm induced by precedex.Intervention provided was to put the patient on extracorporeal membrane oxygenation (ecmo) and impella heart pump.The patient was intubated.However, the patient became ventricular tachycardic (vt), and cardiac massage was performed.After that, the patient left the catheter lab.Extended hospitalization was required after the event.The respiratory assistance devices were removed on (b)(6) 2023.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.
Additional 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 31063496l number, 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).
Additional Manufacturer Narrative
On 2-oct-2023, bwi received additional information indicating that the other products used in this event.It was determined that the octaray was not the most likely device to associate to the adverse event.The thermocool smarttouch has been reported to the fda for the event in question.As a result, the octaray has been determined to be a concomitant product and is not mdr-reportable for this event.No further reports will be sent for this product.All subsequent information will be found on the thermocool smarttouch ablation catheter reports.Manufacturer's reference number: (b)(4).

• Brand Name: OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 17849544
• Report Number: 2029046-2023-02215
• Device Sequence Number: 3453509
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Catalogue Number: D160902
• Device Lot Number: 31063496L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/01/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; IMPELLA HEART PUMP.; NRG TRANSSEPTAL (RF) NEEDLE.; SOUNDSTAR CATHETER.; UNSPECIFIED GENERATOR.; UNSPECIFIED PUMP.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG