MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR NAV CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D140402
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a procedure with a lassostar nav circular mapping catheter for which biosense webster¿s product analysis lab (pal) identified damage on an electrode (partially separated from the tip) and shaft on the loop broken with internal wires exposed.The lassostar nav circular mapping catheter got a defect during pulling it out from the patient.There was no fragment generated during the case.The procedure was completed successfully.No patient consequence.Additional information was received on the event.The lassostar nav circular mapping catheter was not switched.They tried to pull out the lassostar nav circular mapping catheter from the balloon because contrast medium delivery was not possible.When the lassostar nav circular mapping catheter was pulled out, a lassostar nav circular mapping catheter defect probably occurred due to the tightening.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 07-nov-2023, kinks were observed along the shaft, damage on one of the electrodes (partially separated from the tip) and the shaft on the loop was observed broken with internal wires exposed.This event was originally considered non-reportable, however, bwi became aware of the damage on an electrode (partially separated from the tip) and shaft on the loop broken with internal wires exposed on 07-nov-2023 and have assessed these returned conditions as reportable.
Additional Manufacturer Narrative
The device evaluation was completed on 07-nov-2023.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, magnetic sensor functionality test of the returned device.The device was inspected.Kinks were observed along the shaft, damage on one of the electrodes (partially separated from the tip) and the shaft on the loop was observed broken with internal wires exposed.The magnetic sensor functionality was tested on carto and the device failed.Error 116 was observed on the system due to an open circuit on the tip area.That could have been caused by the physical damage to the device.A magnetic issue was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: improperly positioned patches may increase the chances of a virtual magnetic reference move which is unrelated to patient movement.This could also result in inaccurate catheter visualization.In the carto 3 system manual: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device number lot and no internal actions related to the complaint were found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: rod/shaft (g04112) were selected as related to the biosense webster inc.Analysis finding of the ¿kinks were observed along the shaft¿ and the customer¿s reported ¿catheter got defect during pulling it out from the patient¿.-investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿shaft on the loop was observed broken with internal wires exposed¿ and the customer¿s reported ¿catheter got defect during pulling it out from the patient¿.-investigation findings: stress problem identified (c0706) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿damage on electrode¿ and the customer¿s reported ¿catheter got defect during pulling it out from the patient¿.-investigation findings: open circuit (c0205) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sensor (g03012) were selected as related to the biosense webster inc.Analysis finding of the ¿open circuit on the tip area¿ and the customer¿s reported ¿catheter got defect during pulling it out from the patient¿.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Udi related data quality updates only.Correction to the initial mdr, incomplete udi was provided.Section d4.Primary udi number has been updated with full udi (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: LASSOSTAR NAV CIRCULAR MAPPING CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18243829
• Report Number: 2029046-2023-02798
• Device Sequence Number: 12539682
• Product Code: DRF
• UDI-Device Identifier: 10846835020342
• UDI-Public: (01)10846835020342(11)221102(17)231101(10)30946770L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211219
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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: 11/01/2023
• Device Catalogue Number: D140402
• Device Lot Number: 30946770L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10.5FR 28MM BALLOON ABLAT CATH; UNK_GUIDESTAR STEERABLE SHEATH
• Patient Sex: Unknown