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

Catalog Number	D140401
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostar nav and the lasso star packaging was damaged on the inside of the box.The staff had difficulty opening the package and the catheter was contaminated as a result.When the catheter was replaced, the issue was resolved, and the procedure continued.No adverse patient consequence was reported.
Additional Manufacturer Narrative
The biosense webster, inc.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.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lassostar nav and the lasso star packaging was damaged on the inside of the box.The staff had difficulty opening the package and the catheter was contaminated as a result.When the catheter was replaced, the issue was resolved, and the procedure continued.No adverse patient consequence was reported.Device investigation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection of the returned device was performed following j&j procedures.The device was inspected, and no physical damage was observed.Customer inferred that the sterility was compromised in the field.However, the package was not returned for analysis.Due to this condition, further investigation was not possible to perform.A manufacturing record evaluation was performed for the finished device number lot 31362705l and no internal action related to the complaint was found during the review.The sterilization and package issues reported by the customer was not confirmed, due to the package was not returned for analysis.The potential cause of the issue cannot be established.The instructions for use contain (ifu) state the following in the sterilization and use-by date section: the catheter was packaged and sterilized for single use only.Do not reuse, reprocess, or resterilize.Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness, or death.Also, reprocessing or resterilization of single use devices may create a risk of contamination and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another, sepsis, or endocarditis.Contamination of the device may lead to injury, illness, or death of the patient.As part of johnson & johnson medtech'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
• 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: 20582254
• Report Number: 2029046-2024-03531
• Device Sequence Number: 8171160
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: (01)10846835020335(17)250701(10)31362705L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 07/01/2025
• Device Catalogue Number: D140401
• Device Lot Number: 31362705L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: CARTO 3 SYSTEM; GE ULTRASOUND SYSTEM; NGEN GENERATOR; SOUNDSTAR ECO CABLE ASSY 10 FT; UNK_SOUNDSTAR
• Patient Sex: Unknown