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

Catalog Number D128208

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure which included a thermocool® smart touch® sf bi-directional navigation catheter and a pentaray nav high-density mapping eco catheter.The patient experienced cardiac tamponade treated with a pericardiocentesis, surgical repair and extended hospitalization in the intensive care unit (icu).Transseptal puncture performed with brk needle and ablation was performed but no evidence of steam pop.There was a drop in blood pressure in the patient and the patient became tachycardic.Anesthesia vitals were checked as well as electrocardiogram (ekg) and echocardiograms (echo).The pericardial effusion was confirmed by the ultrasound machine.The patient was transported for open heart surgery to locate effusion which was through the left atrial appendage.Most recent report was that the patient has improved.Additional information received on 22-feb-2024 indicated that the event occurred when the pentaray was in the left atrial appendage (laa).The flow for the pentaray was pressurized.With this information, the pentaray is now considered an additional suspected device.The awareness date is 22-feb-2024.The physician's opinion on the cause was that it was procedure related.Correct settings selected on device and no error messages on the bwi equipment during the procedure.

Manufacturer Narrative

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 # 2029046-2024-00768 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2024-00769 for product code d128208 (pentaray nav high-density mapping eco catheter).

Manufacturer Narrative

The device investigation has been completed which included performing a manufacturing record evaluation (mre).A manufacturing record evaluation was performed for the finished device number lot 31202004l and no internal actions related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: PENTARAY NAV HIGH-DENSITY MAPPING ECO 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: 18858061
• MDR Text Key: 337183845
• Report Number: 2029046-2024-00769
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D128208
• Device Lot Number: 31202004L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; BRK TRANSEPTAL NEEDLE; D128208; THMCL SMTCH SF BID, TC, D-F; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male