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

Model Number	BD7TCFJ8L
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 or Problem Description
It was reported that an unknown patient underwent an unknown ablation procedure with a ez steer¿ ds bi-directional electrophysiology catheter.There was a bulge in the distal part of the catheter, with an erosion which seems of the conductor and an abnormal flexion of the distality during flexion.Poor quality of distal signal.The "bulge in the distal part of the catheter" was not a foreign material.No sheath was used.It was unknown if the physician felt any resistance while introducing or retracting the catheter from the sheath or if there was difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter was physically damaged.Procedure was completed successfully.Issue was not resolved.No patient consequences were reported.The damage did not result in wires being exposed or in any lifted or sharp rings.Bad/partial ecg (bs and/or ic) is not mdr-reportable.Deflection issue is not mdr-reportable.Broken tip is mdr-reportable.
Additional Manufacturer Narrative
On 9-jan-2023, 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).
Additional Manufacturer Narrative
On 8-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a ez steer¿ ds bi-directional electrophysiology catheter.There was a bulge in the distal part of the catheter, with an erosion which seems of the conductor and an abnormal flexion of the distality during flexion.Poor quality of distal signal.The "bulge in the distal part of the catheter" was not a foreign material.No sheath was used.It was unknown if the physician felt any resistance while introducing or retracting the catheter from the sheath or if there was difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter was physically damaged.Procedure was completed successfully.Issue was not resolved.No patient consequences were reported.Device evaluation details: visual analysis revealed a curve as a result of the deflection of the device; a tilt test showed that the tip curve was within tolerance.A deflection test and electrical test were performed; the device was deflecting within specifications.No deflection issues were observed; and no electrical issues were found.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.  the deflection and electrical issues reported by the customer could not be replicated during the product investigation; the damage reported could be related to the anchor window that is part of the catheter design.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER.
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15978983
• Report Number: 2029046-2022-03104
• Device Sequence Number: 17613201
• Product Code: LPB
• UDI-Device Identifier: 10846835002607
• UDI-Public: 10846835002607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P950005/S19
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2025
• Device Model Number: BD7TCFJ8L
• Device Catalogue Number: BD7TCFJ8L
• Device Lot Number: 30888946M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 02/08/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/26/2023; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown