MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number	NS7TCDL174HS
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a paroxysmal supraventricular tachycardia with a navistar¿ electrophysiology catheter and the medical team discovered that the handle was dirty even though it had just been opened from its packaging.The dirtiness was white in color, "like a hand stain".Additonally, the cardboard used to hold the navistar catheter in the sterilized bag showed signs of having been wet once.The issue was found immediately after opening the catheter in the sterilized bag.The catheter was replaced with another device (a thermocool smarttouch) and the procedure was completed without problems.No patient consequences were reported.
Additional Manufacturer Narrative
On 4-mar-2024, the bwi 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.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
On 6-may-2024, the product investigation was completed.It was reported that a patient underwent a paroxysmal supraventricular tachycardia with a navistar¿ electrophysiology catheter and the medical team discovered that the handle was dirty even though it had just been opened from its packaging.The dirtiness was white in color, "like a hand stain".Additionally, the cardboard used to hold the navistar catheter in the sterilized bag showed signs of having been wet once.The issue was found immediately after opening the catheter in the sterilized bag.The catheter was replaced with another device (a thermocool smarttouch) and the procedure was completed without problems.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and fourier transformed infrared spectroscopy (ft-ir) of the returned device was performed following bwi procedures.The device was inspected, and no physical damage was observed.According to the photo provided by the customer, the package appeared to have been smashed and ripper as if it had been wet; however, further investigation could not be performed as the packaging was not returned for analysis.It also was observed in the picture a white powdery substance on the length of the catheter and the handle.Due to this condition, fourier transformed infrared spectroscopy (ft-ir), and results exhibit that the foreign material is a mixture mainly conformed of a carbonate-based material.Source of origin and complete material elucidation remains unknown.A manufacturing record evaluation was performed for the finished device 30922836l number, and no internal actions related to the reported complaint condition were identified.The foreign material and sterilization issues reported by the customer were confirmed since the customer refer that the cardboard showed signs of having been wet once.The potential cause of the issues could be related to the damage to the cardboard; however, this cannot be conclusively determined.The instructions for use contain (ifu) the following warning and precaution: the sterile packaging and catheter should be inspected prior to use.Do not use the catheter if the packaging or catheter appears damaged.The catheter was sterilized using ethylene oxide and should be used by the use-by date printed on the product label.Do not use the catheter after the date on the product label.The catheter is intended for single use only.Do not re-sterilize and reuse.As part of biosense webster'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: NAVISTAR¿ ELECTROPHYSIOLOGY 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: 18507560
• Report Number: 2029046-2024-00168
• Device Sequence Number: 15440840
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990025
• 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): 05/31/2024

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: 05/25/2026
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 31077932M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/04/2024; 05/06/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/28/2024; 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: THERMOCOOL SMARTTOUCH
• Patient Sex: Unknown