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

Model Number BN7TCJJ4L

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

Patient Problems Complete Heart Block (2627); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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).

Event Description

It was reported that a female patient ((b)(6), 83kg) with 1st degree atrioventricular (a/v) block prior to the start of the procedure, underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with ez steer¿ nav bi-directional electrophysiology catheter and suffered a complete heart block requiring pacemaker implantation.The event occurred during use of biosense webster products.The catheter position moved posteriorly while ablation was being applied.The catheter was in this position for less than 2 seconds when the energy application was stopped.The physician¿s opinion is that the cause of the event is procedure.Max wattage used for the entire procedure was 35 watts.A temporary pacing lead was placed, and the patient was admitted to the intensive care unit for overnight observation.The patient condition is unchanged.Extended hospitalization was required, the patient had a permanent pacemaker implanted the following day and was discharged to home.

Manufacturer Narrative

Device evaluation was completed on 12/10/2020.It was reported that a female patient (75 year old, 83kg) with 1st degree atrioventricular (a/v) block prior to the start of the procedure, underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with ez steer¿ nav bi-directional electrophysiology catheter and suffered a complete heart block requiring pacemaker implantation.The event occurred during use of biosense webster products.The catheter position moved posteriorly while ablation was being applied.The catheter was in this position for less than 2 seconds when the energy application was stopped.The physician¿s opinion is that the cause of the event is procedure.Max wattage used for the entire procedure was 35 watts.A temporary pacing lead was placed, and the patient was admitted to the intensive care unit for overnight observation.The patient condition is unchanged.Extended hospitalization was required, the patient had a permanent pacemaker implanted the following day and was discharged to home.The device was visually inspected and it and it was found in good conditions.The electrical and temperature features were tested and no issues were observed.In addition, the catheter was deflecting correctly.Then, magnetic sensor functionality was tested on carto and error 105 was observed.A failure analysis was performed.The catheter was dissected and the sensor values were found within specifications.With this information, the failure can be attributed to a potential pc board failure.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.The root cause of the pc board failure cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the use of the device during the procedure.However, this cannot be conclusively determined.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
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10814595
• MDR Text Key: 215488874
• Report Number: 2029046-2020-01651
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835003055
• UDI-Public: 10846835003055
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: BN7TCJJ4L
• Device Catalogue Number: BN7TCJJ4L
• Device Lot Number: 30338280M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CS CATHETER; UNKNOWN BRAND QUAD CATHETER; UNKNOWN BRAND QUAD CATHETER; UNKNOWN BRAND QUAD CATHETER; UNKNOWN BRAND CS CATHETER; UNKNOWN BRAND QUAD CATHETER; UNKNOWN BRAND QUAD CATHETER; UNKNOWN BRAND QUAD CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Weight: 83