MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pseudoaneurysm (2605)

Event Date 08/08/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: darma a, bertagnolli l, torri f, paetsch i, jahnke c, dinov b, hindricks g, arya a.Lv pseudoaneurysm with concomitant mitral valve defect after lv summit ablation: a rare late complication.Jacc case rep.2021 nov 17;3(16):1756-1759.Doi: 10.1016/j.Jaccas.2021.08.008.Pmid: 34825204; pmcid: pmc8603023.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 the lot number was provided by the customer.Manufacturer¿s reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: darma a, bertagnolli l, torri f, paetsch i, jahnke c, dinov b, hindricks g, arya a.Lv pseudoaneurysm with concomitant mitral valve defect after lv summit ablation: a rare late complication.Jacc case rep.2021 nov 17;3(16):1756-1759.Doi: 10.1016/j.Jaccas.2021.08.008.Pmid: 34825204; pmcid: pmc8603023.Objective/methods/study data: a (b)(6)-year-old male patient with highly symptomatic, monomorphic, premature ventricular contractions presented for repeat ablation after failed endocardial ablation.Three weeks after excessive endocardial and epicardial ablation on the left ventricular summit, the patient was admitted again with tamponade following a pseudoaneurysm on the ablation site.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool, biosense-webster, other biosense webster concomitant devices that were also used in this study: carto- 3 system.Non-biosense webster concomitant devices that were also used in this study: agilis transseptal needle, st.Jude medical.Agilis epi, abbott.Adverse event(s) and provided interventions: the patient suffered cardiac tamponade and pseudoaneurysm of the lateral anterobasal wall of the left ventricle.The patient underwent emergency pericardiocentesis, where 500 ml hemorrhagic pericardial effusion was drained, and injury of the coronary arteries was excluded.Given these findings, perforation of the pseudoaneurysm was suspected, and the patient was referred to the surgical department for emergency operation.

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14640928
• MDR Text Key: 293651146
• Report Number: 2029046-2022-01240
• Device Sequence Number: 1
• Product Code: LPB
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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: AGILIS EPI, ABBOTT; AGILIS TRANSSEPTAL NEEDLE, ST. JUDE MEDICAL; CARTO 3 SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention