MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM INTERFACE CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	CB3412CT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system interface cable and foreign material inside the packaging outside of specification issue occurred.There was a tiny piece of cardboard inside the sterile packaging of the carto® 3 system interface cable.The carto® 3 system interface cable was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.Additional information was received.The issue was observed prior to the product being used.The cable was packaged and sent for return before the follow-up email got to the caller.Therefore, the box was not sent.The cable in the original packaging was returned and has not been opened.The foreign object is still in packaging untouched.The caller did not take photos and the product was already packaged for return.The object is a small brown piece of paper/cardboard.The object appeared to be loose, looked like a stray piece of cardboard.The cable was not used.The event was assessed as mdr reportable for foreign material inside the packaging outside of specification.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 24-may-2023.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.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 flutter right (r-afl) procedure with a carto® 3 system interface cable and foreign material inside the packaging outside of specification issue occurred.The device evaluation was completed on 27-jul-2023.The product was returned to biosense webster (bwi) for evaluation.Visual inspection and a fourier transformed infrared spectroscopy (ft-ir) test of the returned device were performed following bwi procedures.Visual analysis revealed that foreign material like a tiny piece of cardboard was observed inside the sterile packaging of the cable.Due to this condition, a manufacturing meeting was performed to determine the root cause of this issue, and it was found that the assignable cause is related to non-compliance with process instructions (pi).An ft-ir test was performed by the manufacturer and the infrared spectrum obtained from the foreign material exhibited the characteristic infrared spectrum for cellulose-base material, presumably a carboard material.Nevertheless, source of the origin remains unknown.The reported failure is confirmed and related to the manufacturing process.A device history record was performed for the finished device batch number, and no internal actions were identified.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: CARTO® 3 SYSTEM INTERFACE CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 17056900
• Report Number: 2029046-2023-01214
• Device Sequence Number: 12946431
• Product Code: DQK
• UDI-Device Identifier: 10846835003796
• UDI-Public: 10846835003796
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K090017
• 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
• Report Date (Section B): 08/24/2023

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: 03/12/2026
• Device Model Number: CB3412CT
• Device Catalogue Number: CB3412CT
• Device Lot Number: 31032937L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: UNKNOWN BRAND CABLE
• Patient Sex: Unknown