MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D134902
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Heart Problem (4454)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30569949l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old male (90kg) patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco catheter and the lasso catheter got caught in the mitral valve which required surgical intervention.After the catheter was inserted into the patient¿s body, during mapping was conducted at the left atrium (la), the lasso got caught in the mitral valve (mv) and could not be removed.Thoracotomy was performed without omission.An emergency surgery was performed to open the chest.The physician commented that although it was not an artificial valve, the tip shape of the lasso slid toward the left ventricle during mapping of the la floor, where it was caught by a structure.The open-chest surgery ended uneventfully.The operation did not require valve replacement, and the patient underwent afib treatment and left atrial appendage (laa) closure with the maze operation.The patient was reported to be in stable condition and has returned to the general ward.The chest opening operation was completed successfully.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related.The patient outcome of the adverse event was reported as improved.There was no device detachment.Since the event is life threatening and required medical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30569949l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old male (b)(6) patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco catheter and the lasso catheter got caught in the mitral valve which required surgical intervention.After the catheter was inserted into the patient¿s body, during mapping was conducted at the left atrium (la), the lasso got caught in the mitral valve (mv) and could not be removed.Thoracotomy was performed without omission.An emergency surgery was performed to open the chest.The physician commented that although it was not an artificial valve, the tip shape of the lasso slid toward the left ventricle during mapping of the la floor, where it was caught by a structure.The open-chest surgery ended uneventfully.The operation did not require valve replacement, and the patient underwent afib treatment and left atrial appendage (laa) closure with the maze operation.The patient was reported to be in stable condition and has returned to the general ward.The chest opening operation was completed successfully.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related.The patient outcome of the adverse event was reported as improved.There was no device detachment.Since the event is life threatening and required medical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 28-feb-2023, it was noted that the code of unspecified heart problem (e0623) more accurately captures the patient's anatomical structure impacted by the surgical intervention required that associated to the suspected device.Therefore, the h 6.Health effect - clinical code has been updated.

• Brand Name: LASSO® NAV ECO 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13015885
• Report Number: 2029046-2021-02199
• Device Sequence Number: 5127329
• Product Code: DRF
• UDI-Device Identifier: 10846835009668
• UDI-Public: 10846835009668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: D134902
• Device Catalogue Number: D134902
• Device Lot Number: 30569949L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 90 KG