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

Model Number D128211

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: initial reporter phone: (b)(4).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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring pericardiocentesis and cardiac arrest requiring percutaneous cardiopulmonary support (pcps) and intra-aortic balloon pump (iabp).At the time of brokenbourough (bb), the radiofrequency (rf) needle tip was not able to be identified on echo.The view was changed several times and the direction of the sheath was changed, but the issue did not change.When the physician approached them again using another combination of sheath and needle, they were able to confirm it on the echo, so bb was performed.After bb, blood pressure decreased after a while when cryo ablation was attempted to be performed after pre-mapping for right atrium (ra).Imaging showed pericardial effusion.Although the patient was treated with pericardial fluid, drainage, and transfusion, cardiac arrest occurred.After introduction of percutaneous cardiopulmonary support (pcps) and an intra-aortic balloon pump (iabp), the patient was transferred to another hospital.Atrial septal puncture was performed with a rf needle.Ablation was not performed before pericardial effusion was identified.Steam pop was not confirmed.There was no irrigation catheter flow rate setting.There was no comment from the physician particularly on the relationship with the jjkk product.Abnormalities were observed prior to use of the product.No abnormalities were observed during use of the product.Additional information was received on (b)(6) 2022.The adverse event occurred on (b)(6)2022.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it is not related with the bwi product.A medtronic generator was used.A transseptal puncture was performed with an rf needle, jll nrg-e-hf-71-c1.The event occurred after mapping, before cryoablation.This was a cryoablation case and no irrigation catheters were reported.This complaint will be conservatively reported under the pentaray as it was reported that the event occurred during mapping.

Manufacturer Narrative

On 27-dec-2022, additional information was received and the physician¿s name was provided.Therefore, the e.Initial reporter section was updated.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 30849178l number, 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.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: 15830613
• MDR Text Key: 303995138
• Report Number: 2029046-2022-02870
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30849178L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2022
• 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: ACUNAV 8F-90; UNK BRAND SHEATH; UNK JAPAN LIFELINE NRG-E-HF-71-C1 RF NEEDLE; UNK MEDTRONIC GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male