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

Model Number	BN7TCFJ4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).The event occurred on (b)(6) 2021.The adverse even was discovered during the use of the bwi products.The heart block was discovered and confirmed via body surface electrograms.The physicians believes that the cause was related to patient condition and procedure.Intervention was external pacing and the implantation of a permanent pacemaker.The patient was in stable condition leaving the ep lab.Patient¿s current condition is unknown.The patient did not require extended hospitalization.No bwi product malfunctions were reported.Since the event required intervention to prevent permanent impairment of a body function, or permanent damage of a body structure, then is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
On 4/12/2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 5/11/2021, the product investigation was completed.It was reported that a female patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).The event occurred on friday, march 12, 2021.The adverse even was discovered during the use of the bwi products.The heart block was discovered and confirmed via body surface electrograms.The physicians believes that the cause was related to patient condition and procedure.Intervention was external pacing and the implantation of a permanent pacemaker.The patient was in stable condition leaving the ep lab.Patient¿s current condition is unknown.The patient did not require extended hospitalization.No bwi product malfunctions were reported.Device evaluation details: visual analysis of the returned product revealed that no damage or anomalies were observed on the ez steer nav (bidirectional) catheter.Per the event, several tests were performed.The magnetic, temperature features were tested, and no issues were observed.In addition, the product was deflecting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30474833m number, and no internal action was found during the review.No malfunction was observed during the product analysis.The instructions for use (ifu) recommended that following: do not exceed 70 watts during ablation.If using a 100 watt generator, program the power to cut off at 70 watts.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the product that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11600774
• Report Number: 2029046-2021-00470
• Device Sequence Number: 14338747
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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: 12/01/2023
• Device Model Number: BN7TCFJ4L
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 30474833M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 05/11/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/21/2021; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention