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

Catalog Number D160901

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cardiac Perforation (2513)

Event Date 01/15/2024

Event Type  Death  

Event Description

It was reported that a patient underwent a cardiac ablation with a thermocool® smart touch® sf bi-directional navigation catheter and an octaray mapping catheter.The patient experienced cardiac perforation/tamponade that required pericardiocentesis and surgical intervention; however, the patient died.Perforation of left atrial roof with the octaray mapping catheter during mapping.Surgical operation (open chest) was performed.Atrial septal puncture was performed by rf needle.Ablation was not performed before pericardial effusion or tamponade was identified.Patient required extended hospitalization but the outcome was patient death.The physician¿s assessment of the health problem was critical.The physician's opinions on the relationship between the event and the product was that perforation may have occurred with either the sheath or the mapping catheter, but which one is unknown.After pre-mapping was performed, the physician noticed a drop in blood pressure during pulmonary vein isolation (pvi).He/she did not notice the drop in blood pressure initially because it could not be confirmed.No abnormalities observed prior to use of the products.Steam pop was not confirmed.Additional information was received.Physician's opinion on the cause of death was cardiac/respiratory arrest due to cardiac tamponade.Since this was the 2nd af procedure, pre-mapping was performed as usual and ablation was performed.After ablation, a drop in blood pressure was noticed, and upon fluoroscopic confirmation, the silhouette of the left ventricle was not moving at all.Tamponade was found near the left atrial roof, so performed drainage immediately.No cardiac or respiratory arrest were observed at that time.Subsequently, as hemostasis was not performed by drainage, contacted surgeon for open chest surgery.Before the chest was opened, the blood pressure was maintained at about 100 mmhg.When the chest was opened, perforation of the roof vein was observed, and pressured hemostasis was performed.Blood pressure at this time was maintained at about 70-80 mmhg.After repairing the damaged roof vein, the patient's condition suddenly got worse.According to the physician, blood had accumulated in abdominal cavity and the abdomen had swelled.Placed the patient on extracorporeal cardiopulmonary bypass, but could not be saved.The sheath was medikit sheath.No issue was reported on the carto 3.Servicing for the carto 3 was not needed at this time.No repair was performed.Probably a perforation occurred by the octaray mapping catheter.No device malfunctions were reported.The adverse event was assessed as mdr reportable under both the thermocool® smart touch® sf bi-directional navigation catheter and an octaray mapping catheter.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, 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: 31153742l 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.Biosense webster manufacturer's reference number: (b)(4) has two reports: (1) mfr#: 2029046-2024-00643 for product code: d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr#: for product code: d160901 (octaray mapping catheter).Manufacturer's reference number: (b)(4).

• 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: 18784671
• MDR Text Key: 336282122
• Report Number: 2029046-2024-00644
• Device Sequence Number: 1
• Product Code: MTD
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D160901
• Device Lot Number: 31153742L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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: JPN CARTO 3 SYSTEM.; MEDIKIT SHEATH.; SOUNDSTAR ECO SMS 8F CATHETER.; THMCL SMTCH SF BID, TC, D-F.; UNK RF NEEDLE.
• Patient Outcome(s): Death; Required Intervention; Hospitalization
• Patient Sex: Male