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

Model Number	D140401
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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 a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostarnav,10p,15mm dia loop and a 28 mm balloon ablation catheter.It was reported that during an afib procedure when trying to introduce the lassostar catheter inside the lumen of the heliostar the lassostar was stuck in the lumen.Several attempts were tried to advance it in the lumen which eventually made its' magnetic sensor malfunctioning.Both catheters were replaced with new ones and the procedure continued and ended successfully.No patient consequences.Size of sheath used was 14f.The incident happened before introducing it to the sheath.The irrigation was reduced to 5ml/min.The catheter was not in the deflected state.The balloon was extended (collapsed).The physician waited 30 seconds until retracting the balloon into the sheath.It was not possible to pass a wire or lassostar through the balloon.Introducer stuck within sheath is mdr-reportable.
Additional Manufacturer Narrative
On 21-mar-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) the g4 section pma/510(k) number was mistakenly omitted from the initial report.It has been updated to k211219.
Additional Manufacturer Narrative
On 3-apr-2023, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostarnav, 10p, 15mm dia loop and a 28 mm balloon ablation catheter.It was reported that during an afib procedure when trying to introduce the lassostar catheter inside the lumen of the heliostar the lassostar was stuck in the lumen.Several attempts were tried to advance it in the lumen which eventually made its' magnetic sensor malfunctioning.Both catheters were replaced with new ones and the procedure continued and ended successfully.No patient consequences.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A dimensional test was performed, and the outer diameters of the device were found within specifications, no issues were observed.The failure reported could be related to the wrong manipulation while introducing the catheter through the lumen; however, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device 30819432l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: if a lassostar¿ catheter is used with the heliostar¿ catheter, do not extend the heliostar¿ catheter beyond the sheath tip until the lassostar¿ catheter has been fully advanced out of the guidewire lumen.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 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: 16464684
• Report Number: 2029046-2023-00435
• Device Sequence Number: 7579064
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2023

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: 05/26/2023
• Device Model Number: D140401
• Device Catalogue Number: D140401
• Device Lot Number: 30819432L
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 04/03/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/29/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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: BALLOON ABLATION CATHETER; HELIOSTAR
• Patient Sex: Unknown