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

Catalog Number UNK_EZ STEER NAVIGATIONAL 4MM

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

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

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a female patient in her late 70¿s (approx.(b)(6)) underwent an atrioventricular nodal reentrant tachycardia ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered an atrioventricular (av) heart block.During the ablation phase, a map shift of 1cm occurred, and no errors displayed on the carto 3 system.When on ablation on the av node, a third-degree heart block was noticed.It was transient and the patient recovered on her own.No medical intervention was provided.A new map was created to continue and the av node burn was completed.After completing the ablation, the physician was looking for the post his and was not able to find it at the mapped location.He checked the prior map and was able to find it.The map had shifted back and again no errors were displayed on the carto 3 system.The green checkbox was on the whole time.The system did not provide any errors and the map shift was discovered by seeing the webster coronary sinus catheter had moved.No cardioversion was performed and the patient did not move during the procedure.The patient was under general anesthesia.The physician¿s opinion was that ventilator settings changed the patient¿s tidal volumes and therefore, it was a possible addition of positive end expiratory pressure which caused the shift in anatomy barring issues being found during the preventive maintenance.No extended hospitalization was required.The patient had fully recovered.Per the physician¿s explanation of the map shift that the ventilator settings changed the patient¿s tidal volumes and therefore, it was a possible addition of positive end expiratory pressure which caused the shift in anatomy, the map shift issue was assessed as not reportable as it will not be considered a malfunction but a result of the patient¿s chest movement.This is then a normal or expected response from the system to not populate an error message.In addition, the carto 3 system was serviced on october 31, 2019 and the backplane was found physically damaged and was replaced.However, the card replacement was not related to the reported map shift.Since this heart block av event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable under the ez steer¿ nav bi-directional electrophysiology catheter.

Manufacturer Narrative

Originally it was reported that the event date was (b)(6) 2019.A correction on the event date was received on 12/29/2019 stating that the correct event date was (b)(6) 2019.Therefore, date of event has been re-populated.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Correction noted on january 3, 2020 to follow-up #2 as after further assessment a second patient code was added on december 17, 2019.Therefore, an additional code was processed for h6.Patient codes.H6: patient code of ¿no code available¿ represents ¿recognized procedural complication." manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information received during investigation.They were performing an electrophysiology study for atrioventricular nodal reentrant tachycardia (avnrt) and did a basic fast anatomical map (fam) of the right atrium.They did not get coronary sinus geometry just the ostium.The coronary sinus catheter was visualized.The coronary sinus and the ablation catheter were the only ones used.The patient was under general anesthesia and the patient became hyper acidic.Therefore, in between them mapping and ablating some ventilator changes were made.The tidal volumes were changed, the rate was changed.They found a spot that looked like a whole pathway and assumed they were about 2cm from the his.Within a few seconds of radio frequency, they had a heart block and immediately came off.Five to 10 seconds later, she was fully recovered.At this point they noticed, based on the ostium of the coronary sinus, that the coronary sinus catheter was in different location.There were no errors, so they decided to re-map and re-mark the his.They went on ablation and it was successful.Before the patient was extubated, they re-marked the his again and there was no his.The physician pulled the first map up and the his was in different location.So the map moved twice.The biosense webster, inc.Representative confirmed that no intervention was required and that the patient had fully recovered.It wasn¿t the intent to ablate in the area of the his initially.The biosense webster, inc.Representative suspects that the his was hit because of the map shift.No errors were displayed.The biosense webster, inc.Representative will try to obtain the carto backup.The physician confirmed that the map shift ventilator settings changed the patient¿s tidal volumes and possible addition of positive end expiratory pressure caused the shift in anatomy.The issue was investigated.It was found that the complaint is related to incorrect patient setup.The patient should lay on back without any supporting items that influence on the back patches vertical axis.It was decided to update the next release of carto 3 instruction for use as follows: "after placing the back patches on the patient, it is recommended that the patient be placed on the table, flat on their back." the map shift issue remains assessed as not reportable as it will not be considered a malfunction but a result of patients chest movement.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: 9350773
• MDR Text Key: 167555030
• Report Number: 2029046-2019-03906
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2019

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 Catalogue Number: UNK_EZ STEER NAVIGATIONAL 4MM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/29/2019; 01/03/2020; 03/09/2020
• Supplement Dates FDA Received: 12/30/2019; 01/03/2020; 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; WEBSTER CORONARY SINUS CATHETER
• Patient Outcome(s): Other
• Patient Weight: 75