MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number BN7TCDF4L

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

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot# 30338306m, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a female patient (b)(6) year old underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with ez steer¿ nav bi-directional electrophysiology catheter and suffered complete heart block requiring pacemaker implant.It was reported by the caller that while performing an atrioventricular nodal reentrant tachycardia (avnrt) ablation the av node was ablated requiring the patient to get a permanent pacemmaker implanted.The caller stated that they mapped and took a his point with the decanav catheter.The physician started pacing with the 4mm catheter and found a "good spot".According to the clinical account specialist, there was a small "a" signal and a big "v" signal.Radiofrequency (rf) therapy was delivered for about 10-20 seconds, there were slow junctional beats, the lesion set was "close to the coronary sinus ostium, a little high and posterior than normal." about 1 min and 30 seconds into ablation time, they noticed a slight prolongation on two cardiac beats, rf ablation was stopped.The patient¿s cardiac rhythm changed to asystole, the physician had a quad catheter in the right ventricle, the physician paced the right ventricle to get an intrinsic ventricular cardiac beat.The physician confirmed the patient's cardiac rhythm, mobitz ii av block, and administered 5 mcg of isoproterenol.After some time, the physician noted that the cardiac rhythm (mobitz ii av block) had not changed, and the decision to implant a permanent pacemaker was made.The physician implanted a his and atrial lead, and the patient was stabilized.The caller confirmed there was no patient movement during the procedure and no errors or messages on any biosense webster products.The physician thought it was a decent area, cleared on the av node.The event occurred during use, once noticed that there was prolongation of pr interval the ablation was terminated.The physician¿s opinion is that the cause of the event was procedure and patient¿s condition.Patients are made aware before every supraventricular tachycardia (svt) procedure that if the svt is avnrt there is a risk of injuring the av node.Unfortunately, this patient¿s anatomy was a little different, and the av node was damaged.After prolongation rf was stopped.The patient then went into asystole.We immediately paced the rv off a quad that was located in the rv apex.Isoprotenyal was administered to increase heart rate.The patients intrinsic did come back but unfortunately at 2nd degree av block.After waiting an hour, nothing improved, so the decision was made to implant a pacemaker (one lead was atrial and the other lead was situated in the his region).Patient improved after receiving a pacemaker.The patient stayed overnight which was required by the physician after receiving a pacemaker.Asystole is considered cascade of harms from the av block and thus is not coded.

• Brand Name: EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10594363
• MDR Text Key: 208949602
• Report Number: 2029046-2020-01353
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

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 Expiration Date: 01/16/2023
• Device Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 30338306M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR