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

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal re-entrant tachycardia (avnrt) cardiac ablation procedure which included an ez steer¿ nav bi-directional electrophysiology catheter and the patient experienced cardiac heart block treated with implantation of pacemaker and extended hospitalization.The patient was mildly sedated with propofol.There was the team of anesthesiologists in charge of the sedation of the patient.The case started and the physician placed the decanav catheter in the coronary sinus (cs), and right ventricle (rv) catheter (non-biosense), and the 4mm ablation catheter (ez steer¿ nav bi-directional electrophysiology catheter).The electrophysiology (ep) study was performed, and it was decided to perform an avnrt ablation.The physician first marked his points and then marked with a point a good location for ablation.During this process, the patient was moving the legs.Two assistant doctors tried to maintain the body and legs (without moving) by holding them.The physician performed several ablations.The last ablation lasted for 20s, during which there was some slow junctional beats which showed that the ablation was being performed in the slow pathway area of the atrioventricular (av) node.The patient suddenly moved.Ablation was stopped in 1.4s after the movement.The error of "patient moved" appeared on the carto system, and the catheters could not be visualized anymore.After the movement, the patient had an av node block that persisted.The physician gave isuprel, but there was still av dissociation.The patient left the lab with av node block.The physician believed that the block was produced by the sudden movement of the patient with the catheters inside the heart, and not related to the ablation.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient had no symptoms but had a rather low heart rate (junctional rhythm at a rate of 40-50bpm) so they decided to implant a pacemaker.The patient¿s condition improved and was discharged.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular nodal re-entrant tachycardia (avnrt) cardiac ablation procedure which included an ez steer¿ nav bi-directional electrophysiology catheter and the patient experienced cardiac heart block treated with implantation of pacemaker and extended hospitalization.The patient was mildly sedated with propofol.There was the team of anesthesiologists in charge of the sedation of the patient.The case started and the physician placed the decanav catheter in the coronary sinus (cs), and right ventricle (rv) catheter (non-biosense), and the 4mm ablation catheter (ez steer¿ nav bi-directional electrophysiology catheter).The electrophysiology (ep) study was performed, and it was decided to perform an avnrt ablation.The physician first marked his points and then marked with a point a good location for ablation.During this process, the patient was moving the legs.Two assistant doctors tried to maintain the body and legs (without moving) by holding them.The physician performed several ablations.The last ablation lasted for 20s, during which there was some slow junctional beats which showed that the ablation was being performed in the slow pathway area of the atrioventricular (av) node.The patient suddenly moved.Ablation was stopped in 1.4s after the movement.The error of "patient moved" appeared on the carto system, and the catheters could not be visualized anymore.After the movement, the patient had an av node block that persisted.The physician gave isuprel, but there was still av dissociation.The patient left the lab with av node block.The physician believed that the block was produced by the sudden movement of the patient with the catheters inside the heart, and not related to the ablation.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient had no symptoms but had a rather low heart rate (junctional rhythm at a rate of 40-50bpm) so they decided to implant a pacemaker.The patient¿s condition improved and was discharged.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed that the rocker arm was detached from the handle.However, welding residues were observed that showed that the rocker arm was correctly attached.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31132670m and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.The root cause of the adverse event remains unknown.The potential cause of the rocker arm detached could be related to the manipulation of the device after the procedure.The physician¿s opinion on the cause of this adverse event was the procedure.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event reported on the patient.Investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15) / component code: actuator (g04002) were selected as related to the rocker arm that was detached from the handle.Manufacturer's reference number: (b)(4).

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 18802883
• Report Number: 2029046-2024-00671
• Device Sequence Number: 15261632
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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 Expiration Date: 09/17/2026
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31132670M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM; NGEN RF GENERATOR; NON-BIOSENSE WEBSTER INC. CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown