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

Catalog Number	CR3434CT
Medical Device Problem Codes	Overheating of Device (1437); Failure to Transmit Record (1521); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a carto® 3 system interface cable and burnt marks were found on the inside pin area.Upon preparing everything for the doctor to start the procedure, error 101 was noticed related to the ablation catheter.The scrub tech was asked to disconnect it and the piu too would also be unplugged.Only when she disconnect the catheter from its cable the scrub tech identified both the catheter and connector had a burnt mark on the inside pins.Both the connector and the catheter were replaced.After that, the procedure was completed successfully and there was no patient consequence.Additional information was received indicating there were no signs of any visible file, flame or smoke.It was more so that the connector experienced a short circuit or something that caused burn marks on the pins where it joins the catheter.
Additional Manufacturer Narrative
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.G1.Manufacturer site phone: +52 664 627 7200/+52 663 3236806 if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number pc-001589446 has two reports: (1) mfr # 2029046-2024-01556 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2024-01555 for product code cr3434ct (carto® 3 system interface cable).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a carto® 3 system interface cable and burnt marks were found on the inside pin area.Upon preparing everything for the doctor to start the procedure, error 101 was noticed related to the ablation catheter.The scrub tech was asked to disconnect it and the piu too would also be unplugged.Only when she disconnect the catheter from its cable the scrub tech identified both the catheter and connector had a burnt mark on the inside pins.Both the connector and the catheter were replaced.After that, the procedure was completed successfully and there was no patient consequence.Device evaluation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.The lot number reported by the customer was unrecognized as a valid lot number.As a result, the mre review cannot be conducted.Should the correct lot number be made available at a later date, the complaint file will be reopened and an mre review will be performed and documented.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Correction: on 29-aug-2024, the medical device problem code has been corrected in field h6 from insufficient information (a26) to overheating of device (a1005).Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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): FOXCONN BAJA CALIFORNIA; parque industrial el lago; tijuana
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19287385
• Report Number: 2029046-2024-01555
• Device Sequence Number: 15221419
• Product Code: DQK
• UDI-Device Identifier: 10846835003871
• UDI-Public: 10846835003871
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: CR3434CT
• Device Lot Number: F100000452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THMCL SMTCH SF BID, TC, D-F; UNK_CARTO 3
• Patient Sex: Male