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

Catalog Number	UNK_NAVISTAR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: jiwani s, akhavan d, reddy m, noheria a.Cardiac stereotactic radiotherapy for refractory ventricular tachycardia in a patient with wireless left ventricular endocardial stimulation system.Heartrhythm case rep.2023 sep 1;9(11):818-822.Doi: 10.1016/j.Hrcr.2023.08.013.Pmid: 38023677; pmcid: pmc10667127.Objective/methods/study data: case report of 83 year old man with history of coronary artery disease, ischemic cardiomyopathy with lv apical infarct and lv ejection fraction (lvef) (b)(6), chronic nyha class iii heart failure status post cardiac resynchronization therapy (crt) defibrillator placement, recurrent vt, underlying left bundle branch block, paroxysmal atrial fibrillation, and chronic kidney disease.He had multiple presentations with sustained vt requiring implantable cardioverter-defibrillator (icd) shocks, which continued despite amiodarone and mexiletine.He underwent endocardial lv catheter mapping/ablation with navistar (biosense webster, irvine, ca) remote magnetic navigation catheter.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar ablation catheter.Concomitant biosense webster devices that were used in this study: n/a.Concomitant non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified navistar ablation catheter: qty (b)(4) pericardial effusion requiring emergent pericardiocentesis but no surgical intervention (cardiac tamponade)(recognized procedural complication).
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: jiwani s, akhavan d, reddy m, noheria a.Cardiac stereotactic radiotherapy for refractory ventricular tachycardia in a patient with wireless left ventricular endocardial stimulation system.Heartrhythm case rep.2023 sep 1;9(11):818-822.Doi: 10.1016/j.Hrcr.2023.08.013.Pmid: 38023677; pmcid: pmc10667127.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 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 ref # (b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18938525
• Report Number: 2029046-2024-00939
• Device Sequence Number: 17903146
• Product Code: DRF
• UDI-Device Identifier: 10846835008531
• UDI-Public: 10846835008531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_NAVISTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown