MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number UNK_NAVISTAR

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

Patient Problems Cardiogenic Shock (2262); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 10/01/2021

Event Type  Death  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 complaints that are related to the same article.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.Literature citation: lawrenz t, lawin d, radke k, stellbrink c.Acute and chronic effects of endocardial radiofrequency ablation of septal hypertrophy in hocm.J cardiovasc electrophysiol.2021 oct;32(10):2617-2624.Doi: 10.1111/jce.15203.Epub 2021 aug 16.Pmid:(b)(6).Objective/methods/study data: authors aimed to report the outcomes of 41 patients who underwent: endocardial radiofrequency ablation of septal hypertrophy (erash) with a focus on severe complications.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar concomitant other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: 8f agilis sheath (st.Jude) adverse event(s) and provided interventions possibly associated with ablation catheter: qty 2 pericardial tamponade caused by perforation of the rv pacing catheter (one treated with pericardial drainage and the treated surgically due to ongoing bleeding after pericardial drainage) qty 4 patients experienced paradoxical increase in obstruction (pio) beginning suddenly at approximately 30 min after the initial successful procedure of erash.Qty 2 from the 4 patients that experienced pio resulted in acute massive mitral regurgitation (one led to death due to cardiogenic shock and the other successfully treated with rescue pump and emergency surgical myectomy) qty 2 steam pop (one with severe pio and the other moderate pio).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14719161
• MDR Text Key: 294232488
• Report Number: 2029046-2022-01340
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8F AGILIS SHEATH (ST. JUDE); CARTO
• Patient Outcome(s): Life Threatening; Death