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

Model Number	D140403
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation cardiac ablation procedure with an unknown lasso diagnostic catheter and experienced a phrenic nerve palsy.Devices used during the case: - carto3 system (sn (b)(4) / v7.2.40.250), ngen generator (sn (b)(4) ), ngen pump (sn (b)(4).The caller confirmed that no other biosense webster devices have been used.Catheter used during the case: helios star balloon, guides star, and lasso star it was reported that all catheters have been discarded; therefore, no lot numbers could be provided.The bwi representative confirmed that they did not have any issue on the system but it was reported that the patient had a phrenic nerve palsy during the ablation of the right pulmonary vein.The patient is alive.Procedure has been completed.No delay.
Additional Manufacturer Narrative
Initial reporter phone : (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

• Brand Name: LASSOSTAR NAV
• 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: 16680012
• Report Number: 2029046-2023-00718
• Device Sequence Number: 7190570
• Product Code: DRF
• UDI-Device Identifier: 10846835020359
• UDI-Public: 10846835020359
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 04/05/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: D140403
• Device Catalogue Number: UNK_LASSOSTAR CATHETER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; CARTO 3 SYSTEM; GUIDESTAR SHEATH, 14F; NGEN PUMP, EU CONFIGURATION; NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown