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

Model Number D128211

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bradycardia (1751)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

(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 number lot 30873580l 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).

Event Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter.The patient experienced a pericardial effusion and a bradycardia requiring surgical intervention.It was reported that after atrial septal puncture, during mapping at the left ventricle (lv) using the pentaray, the bradycardia occurred.The temporary pacemaker was implanted to right ventricle (rv).After that, decreased blood pressure was found, and pericardial effusion was confirmed by echocardiography.Timing when complaints occurred was 30 to 60 minutes after performing the atrial septal puncture.Although there was a possibility that the bleeding was from the right heart due to the venous bleed caused by cardiac puncture, the bleeding did not stop.The patient was treated with infusion, blood transfusion, and vasopressor.After waiting for about two hours, blood pressure was confirmed to be maintained, and then the procedure was completed without conducting the ablation.Atrial septal puncture was performed by rf needle.Ablation was not conducted.The physician's opinions on the relationship between the event and the product was that jjkk products were not relevant because the adverse event was most likely caused during septal puncture or rv lead placement of the temporary pacemaker.There were no abnormalities observed prior to and during use of the product.Additional information: the adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that jjkk products were not relevant because the adverse event was most likely caused during septal puncture or rv lead placement of the temporary pacemaker.Although there was a possibility that the bleeding was from the right heart due to the venous bleed caused by cardiac puncture, the bleeding did not stop.The patient was treated with infusion, blood transfusion, and vasopressor.Smartablate generator, the serial number was unknown.Transseptal puncture was performed, rf needle was used.Ablation was not performed.The event occurred during the transseptal phase.30 to 60 minutes after performing the atrial septal puncture.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 and mdr-reportable.

Manufacturer Narrative

On 16-mar-2023, bwi received additional information regarding the event.The patient's state was improved.After that, implantation crt-p (cardiac resynchronization therapy) was performed.As for the duration of hospitalization period, cardiac failure was present as medical history, so it cannot be said that hospitalization was extended due to this adverse event.[relevant medical history]: cardiac failure.[relevant tests/laboratory data]: unknown.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 ECO
• 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: 16551180
• MDR Text Key: 311373257
• Report Number: 2029046-2023-00545
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 30873580L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2022
• 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: DECANAV CATHETER.; JJKK NEEDLE.; RF NEEDLE.; SMARTABLATE GENERATOR.; SOUNDSTAR ECO CATHETER.; VIZIGO SHEATH.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female