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

Model Number	D134301
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a lasso® nav eco variable catheter and a brown stain was found on the inside of the package.It was reported that a brown stain was found on the inside of the package before opening the catheter.The catheter was not used and was resolved by using another catheter from a different lot.The procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this issue was assessed as a mdr reportable product malfunction.
Additional Manufacturer Narrative
Initial reporter name and address: initial reporter phone: (b)(6).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 4.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
The device evaluation was completed on 10-nov-2022.It was reported that a patient underwent a cardiac ablation procedure with a lasso® nav eco variable catheter and a brown stain was found on the inside of the package.It was reported that a brown stain was found on the inside of the package before opening the catheter.The catheter was not used and was resolved by using another catheter from a different lot.The procedure was completed without patient consequence.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, a brown stain was observed on the package of the catheter.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, fourier transformed infrared spectroscopy (ftir) and scanning electron microscope (sem) study of the returned device was performed in accordance with bwi procedures.Visual analysis revealed no damage or anomalies on the device; however, a stain of foreign brown material was observed on the plastic tray.No significant information was obtained through the ftir study as the tray¿s material obscured the other materials.A sem study was performed, and traces of sulfur (s), oxygen (o) and calcium (ca) were found, however, the composition of the brown stain could not be determined with this amount of information.A manufacturing investigation had to be performed to verify this issue: based on the evidence that proves that all the controls to detect this damage were in place and being followed as prescribed, no deviations from the procedures were found, and all the personnel involved was trained and certified accordingly, it was determined that this issue is related to manufacturing as there are inspections that have to be performed to verify that the tray is not contaminated.A ftir study was also performed by the supplier of the plastic tray and determined that the brown stain came from the raw material purchased from an extrusion supplier.An awareness session was performed for all the personnel involved.A manufacturing record evaluation was performed for the finished device 30834373l, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: LASSO® NAV ECO VARIABLE 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15263729
• Report Number: 2029046-2022-01941
• Device Sequence Number: 17768309
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• 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): 12/08/2022

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: 06/02/2025
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30834373L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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: UNK_LASSO
• Patient Sex: Unknown