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

Catalog Number	D1085413
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster catheter.There was a hair present inside of the sterile packaging of the webster catheter.The webster catheter was replaced and the procedure continued.There was no patient consequence reported.Additional information was received.The issue was noticed before use and therefore, not used on the patient.If they have not already, they will ship back all the materials.
Additional Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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
The bwi product analysis lab received the device for evaluation on 15-aug-2024.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
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster catheter.There was a hair present inside of the sterile packaging of the webster catheter.The webster catheter was replaced and the procedure continued.There was no patient consequence reported.The investigation was completed on 23-aug-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual inspection was performed and no foreign material was observed.However, according to the photo provided by customer, a foreign material-like a hair was observed inside the sterile package; however, further investigation could not be performed as the packaging was not returned for analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material issue was confirmed based on the photo provided by the customer.The potential cause of the contamination issue cannot be established, since the packaging was not returned for analysis.The instructions for use contain (ifu) the following statement: the sterile packaging and catheter should be inspected prior to use.If the package or the catheter appears damaged, do not use.Contact your local biosense webster representative.During an internal review on 14-sep-2024, noted a correction to the 3500a initial under d4.Primary udi number as it should have been processed as (b)(4).Manufacturer¿s reference number: (b)(4).

• Brand Name: WEBSTER
• 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: 19982702
• Report Number: 2029046-2024-02686
• Device Sequence Number: 2760857
• Product Code: DRF
• UDI-Device Identifier: 10846835010114
• UDI-Public: (01)10846835010114(17)270215(10)31257920M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2024

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 Catalogue Number: D1085413
• Device Lot Number: 31257920M
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 08/23/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/20/2024; 09/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: UNK_SMARTABLATE GENERATOR
• Patient Sex: Unknown