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

Catalog Number BN7TCDF4L

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

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

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.No code available was used to represent surgical intervention required for pacemaker implantation.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a female patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered atrioventricular heart block 3rd degree requiring pacemaker implantation.During the procedure, heart block av 3rd degree was discovered and confirmed by electrocardiogram (ecg).A pacemaker implantation was required.The patient was reported in stable condition.Extended hospitalization was required as a result of the adverse event.Patient¿s outcome was unchanged.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.No bwi product malfunctions were reported.Follow up to obtain additional details regarding the event is in progress.Should any new information be obtained it will be assessed and processed accordingly.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9107903
• MDR Text Key: 161360463
• Report Number: 2029046-2019-03681
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2019

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 Expiration Date: 05/13/2022
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 30222036M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 85 YR