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 Bradycardia (1751); Cardiac Arrest (1762); Ischemic Heart Disease (2493)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 an unknown ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered a bradycardia, electrocardiogram st segment elevation and cardiac arrest.It was reported that mapping was performed with pentaray after septal puncture and communicate between ra and la.After that, the sheath introducer was switched to a new sheath for cryo-balloon catheter, and when it was inserted, st elevation was found on 12lead ecg.The patient also became bradycardic, and because of the possibility of air contamination, air aspiration was to be performed while cardiac massage was performed.Blood pressure was decreased at 40-50 mmhg and the patient was in shock vitals, so the procedure was interrupted, and the patient was moved to life-saving measures.Version information: v7.1.80.33.Timing was an hour after the catheter was inserted into the patient's body.Prolonged hospitalization was required.Physician's opinion (comment) on the relationship between this event and the product was that the carto product was unrelated.No product abnormalities were observed before use.Relevant medical history: atrial fibrillation.The procedure was completed without patient's consequence.The complaint product(s) will not be returned for analysis.Carto 3 ver.7.1.80.33.Additional information -intervention provided was that air aspiration was to be performed while cardiac massage was performed.In addition, life-saving measures were conducted.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.

• 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: 16912898
• MDR Text Key: 315032630
• Report Number: 2029046-2023-01002
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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: CARTO 3 SYSTEM; UNSPECIFIED CRYO BALLOON
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 56 KG