MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BN7TCDF8L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female ((b)(6) kg) patient with history of left-sided accessory pathway conduction, underwent an atrioventricular reentrant tachycardia (avrt) /wolff-parkinson-white (wpw) ablation procedure with an unknown ez steer¿ nav ds bi-directional electrophysiology catheter and suffered complete heart block with conduction through left-sided accessory pathway.During the avrt procedure, after use of bwi products, wherein no ablation was performed, an av node block was discovered as the shape of the qrs on the carto 3 and the recording system changed.The physician confined it after pacing near the av node and the system was not using the av node.No medical intervention was offered.The patient was under monitoring as this may be temporary and the conduction can return.Patient was still able to conduct from atria to ventricles during complete heart block due to presence of accessory pathway.The patient was reported to be in a stable condition.The patient did require extended hospitalization stay because of the adverse event.The physician recommended admitting patient overnight to monitor heart block and conduction.The physician¿s opinion on the cause of this adverse event is that it was procedure related as the physician believes he bumped av node with baylis trans-septal needle while positioning it.On follow up it was stated that the patient was fully recovered (no residual effects).

• Brand Name: EZ STEER NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11600819
• Report Number: 2029046-2021-00473
• Device Sequence Number: 3544546
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: 10846835003000
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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 Model Number: BN7TCDF8L
• Device Catalogue Number: BN7TCDF8L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/01/2021
• 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: Hospitalization
• Patient Age: 11 YR
• Patient Weight: 40