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

Catalog Number	D134301
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure using a lasso nav catheter.The patient experienced pericardial effusion that required prolonged hospitalization and procedure cancellation.After a fast anatomical mapping (fam) of the left atrium (la) was completed with the lasso catheter, the physician noticed that there was a pericardial effusion on intracardiac echocardiography (ice).The effusion was not present at the start of the procedure (verified with ice).As a precaution, the physician preferred to stop the procedure without any ablation the procedure was terminated.The effusion was monitored and did not worsen.The patient was in stable condition.The patient did not require a pericardial drain and recovered without further intervention.The patient required extended hospitalization and was monitored overnight.Patient has fully recovered.The physician does not believe the complication is related to any biosense webster catheters.He thinks it may have occurred during the transseptal puncture.Event occurred after the transseptal phase, after the la mapping phase, before the ablation phase.Transseptal puncture was performed with baylis rf needle.No evidence of steam pop and no ablation was performed prior to noting pericardial effusion.
Additional Manufacturer Narrative
Additional information was received on 23-oct-2023.It was reported that an abbott sl1 sheath was used during the transseptal.No biosense webster inc.(bwi) sheath was used.As such, the concomitant product section was updated.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30837967l 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.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: LASSO NAV 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: 17945164
• Report Number: 2029046-2023-02333
• Device Sequence Number: 20777655
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: (01)10846835009637(11)220617(17)250616(10)30837967L
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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 Expiration Date: 06/16/2025
• Device Catalogue Number: D134301
• Device Lot Number: 30837967L
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/23/2023; 07/11/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/15/2023; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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: ABBOTT SL1 SHEATH.; ACUNAV G 8F-90 CATHETER.; BAYLIS RADIOFREQUENCY NEEDLE.; CARTO 3 SYSTEM.; SMARTABLATE GENERATOR KIT-WW.; THMCL SMTCH SF BID, TC, D-F.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male