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

Model Number BN7TCDF4L

Device Problems Image Orientation Incorrect (1305); Application Program Problem (2880); Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

On 2/8/2021, the bwi product analysis lab received the complaint device for evaluation.Initial visual analysis found the catheter in good, normal condition.The product 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.Since the ez steer¿ nav bi-directional electrophysiology catheters used were of the same product code and the same lot number the reportable patient adverse event will be reported against both.Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2021-00165 for product code bn7tcdf4l (ez steer¿ nav bi-directional electrophysiology catheter).Mfr # 2029046-2021-00166 for product code bn7tcdf4l (ez steer¿ nav bi-directional electrophysiology catheter).

Event Description

It was reported that a (b)(6)-year-old female patient with history of supraventricular tachycardia (svt), underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and suffered atrioventricular (av) heart block 3rd degree requiring surgical intervention (pacemaker implantation) and steroids administration.While ablating the slow pathway, an av 3rd degree heart block was noticed.The heart block was confirmed by the electrogram.Intravenous (iv) steroids were given to the patient.After the steroids administered, the patient was monitored for 45 minutes.The patient was reported to be in stable condition but is still in third-degree heart block.A temporary pacemaker was implanted.Prolonged hospitalization was required to monitor the patient and to possibly implant a permanent pacemaker.It is unknown if a permanent pacemaker was later implanted.Patient condition unchanged.Physician did not give any reason or cause for the issue.He maintained adequate distance from his and used products within the instructions for use (ifu).Catheter was replaced.It was also reported that during the procedure there was an issue with one the ez steer¿ nav bi-directional electrophysiology catheter as it was appearing ¿reversed¿ on the carto 3 system; the catheter was replaced with another one from the same lot # and the issue was resolved.The carto 3 system was displaying a 401-"catheter sensor error." the cable was replaced without resolution.The carto 3 system was rebooted without resolution.The ez steer¿ nav bi-directional electrophysiology catheter, the catheter was replaced.The reported reversed icon and sensor errors are not considered to be mdr reportable malfunction since the issues are highly detectable issue.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

On (b)(6) 2021, biosense webster inc.Received additional information indicating there were three (3) ez steer¿ nav bi-directional electrophysiology catheter used during this procedure.The reversed image issue occurred with the very first ez steer¿ nav bi-directional electrophysiology catheter used and that was well before any ablation.The second ez steer¿ nav bi-directional electrophysiology catheter had the 401 error.The third ez steer¿ nav bi-directional electrophysiology catheter was used to map and ablate the patient who subsequently had the complication.Based on this new information, it has been determined the reportable adverse event will be reportable only against the third catheter under metwatch report # 2029046-2021-00373.The adverse event is no longer reportable against this catheter since the reversed icon issue is not an mdr reportable malfunction.Manufacturer's ref.# (b)(4).

• 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
• MDR Report Key: 11322702
• MDR Text Key: 240316100
• Report Number: 2029046-2021-00165
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 30429402M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4MM NAVIGATIONAL BI-DIRECT; CARTO 3 SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR