MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D135304
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt ¿ left) ablation procedure with a webster cs catheter with auto id technology and the catheter breakage occurred.It was reported that during use of the webster cs catheter with auto id technology, the catheter broke when the physician introduced it into coronary sinus and the catheter could not be seen after this damage.The procedure was delayed 2 minutes and a new catheter was used to successfully complete the procedure.There was no patient consequence.It is unknown if fragments were generated.Additional exams have been done (scanner) and waiting for results.Additional information was later received indicating the damage resulted in wires and/or braid being exposed; the physician saw wires.It is unknown if the damage resulted in any lifted or sharp rings.The physician did not notice any resistance or difficulty during insertion or removal of the device.There was no loss of material.No part was detached just catheter break up without loss of material.The physician didn¿t use a sheath for this catheter.A computed tomography (ct) scan has been done but it was normal.Physician¿s opinion on the cause of the event is bwi product malfunction.Patient outcome is fully recovered (no residual effects).The patient did not require extended hospitalization.This event will be reported as malfunction only as the current information indicates no medical or surgical intervention were required or prolonged hospitalization for the patient.Should additional information become available regarding a patient harm this can be reassessed for adverse event.
Additional Manufacturer Narrative
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt ¿ left) ablation procedure with a webster cs catheter with auto id technology and the catheter breakage occurred.It was reported that during use of the webster cs catheter with auto id technology, the catheter broke when the physician introduced it into coronary sinus and the catheter could not be seen after this damage.Additional information received indicated the damage resulted in wires and/or braid being exposed; the physician saw wires.The procedure was delayed 2 minutes and a new catheter was used to successfully complete the procedure.There was no patient consequence.Device evaluation details: on 14-feb-2022, the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and functional tests of the returned device.Visual analysis revealed that the shaft-tip transition was damaged.An outer diameter evaluation was performed, according bwi procedures.The device was found within specification.The issue experienced by the customer cannot be associated to the dimensions of the device.Also, a microscopic examination was performed, and adhesive marks were observed on the shaft-tip transition as evidence that the device was properly assembled.All units are inspected prior to leaving the facility to avoid this type of damage.The issue could be related to excessive force or manipulation, but this cannot be determined.With the available information, it can be concluded that the issue occurred outside the manufacturing environment.A manufacturing record evaluation was performed for the finished device [30614418m] number, and no internal action related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.The instructions for use contain the following precaution: "do not use excessive force to advance or withdraw the catheter when resistance is encountered".If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13091167
• Report Number: 2029046-2021-02254
• Device Sequence Number: 11264591
• Product Code: DRF
• UDI-Device Identifier: 10846835009989
• UDI-Public: 10846835009989
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 09/08/2024
• Device Model Number: D135304
• Device Catalogue Number: D135304
• Device Lot Number: 30614418M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR CS,F,10 POLE,12 PIN,AUTOID; SMARTABLATE GENERATOR KIT-WW
• Patient Sex: Unknown