MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number R7F282CT

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/07/2023

Event Type  Death  

Event Description

It was reported a patient underwent a redo paroxysmal atrial fibrillation cardiac ablation procedure which included the use of a decanav electrophysiology catheter.The patient suffered a cardiac arrest and has died.Patches on, the decanav electrophysiology catheter was in the coronary sinus (cs), transseptal performed under fluoroscopy and pentaray in the left atrium (la) ready to map.Patient then lost cardiac output and cpr was commenced.At this point, all equipment was removed from the la.A short time later (perhaps 10minutes), the decanav electrophysiology catheter was removed from the cs).Resuscitation attempts continued for 80 minutes.Over this time, the rhythm degenerated into ventricular fibrillation (vf) multiple times with some successful shocks and finally pulseless electrical activity (pea).There was no evidence of pericardial effusion, no pneumothorax.No reversible causes on blood gas.There was no ischemic cause upon doing a coronary angiogram.Left ventricle (lv) gram showed little contractility with some aortic regurgitation.Following this a balloon pump was inserted.Physician were unsure whether the cause could have been an anaphylactic reaction to a drug.Patient unfortunately was pronounced deceased and the case is for the coroners.Patient had previous af ablation with carto, dcm (dilated cardiomyopathy) and a biventricular defibrillator device.He had an appropriate shock last year for vf.Physician¿s opinion on the cause of this adverse event is the patient's condition.No ablation was performed.No ablation catheter used.

Manufacturer Narrative

E1.Initial reporter phone:(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 reference number: (b)(4).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: 18243767
• MDR Text Key: 329428283
• Report Number: 2029046-2023-02797
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

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: R7F282CT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• 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: PATCHES; PENTARAY; UNK BALLOON PUMP
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 68 YR
• Patient Sex: Male