MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D160901

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ischemic Heart Disease (2493); Heart Block (4444)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 number lot 31062346l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation with a octaray mapping catheter and the patient experienced st segment elevation that required pacing.During preparation for left atrial mapping using an octaray mapping catheter, st-segment elevation was observed by induction of the inferior wall of the body surface.Issue occurred after pulmonary vein isolation (pvi) was performed and immediately after post-mapping was started.Post-mapping was immediately terminated, and coronary angiography was prepared.Right coronary artery (rca) angiography showed no air embolism.The patient developed atrioventricular block and the consciousness level decreased, so an rv catheter was inserted and backup pacing was performed.St returned to normal spontaneously, and the patient was discharged from the operating room after confirming that the vitals were stable.Subsequent computed tomography (ct) showed no abnormalities.According to the physician, the patient had drug allergy caused by sedation (precedex), which may have resulted in a decrease in blood pressure and coronary artery spasm, leading to transient myocardial ischemia.Patient has a history of ischemic heart disease (stent in left anterior descending artery).No abnormalities observed prior to during use of the product.Patient fully recovered.Patient did not require extended hospitalization.

• Brand Name: OCTARAY MAPPING CATHETER
• Type of Device: 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: 18984405
• MDR Text Key: 338658220
• Report Number: 2029046-2024-01031
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Catalogue Number: D160901
• Device Lot Number: 31062346L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male