MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	NI75TCBH
Medical Device Problem Codes	Break (1069); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(4).Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip was observed broken at the peek housing section with exposed wires.A manufacturing record evaluation was performed for finished device number 30908249m, and no internal actions related to the reported complaint condition were identified.However, the physical device was not yet returned.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 supraventricular tachycardia (svt) procedure with a navistar thermocool: however, the device was damaged within the packaging.The device was found to have been cracked when the package was opened (with some wires exposed).A second device was used to complete the operation.There was no adverse event reported on patient.The device wasn¿t used on the patient.Out of box failure is not mdr-reportable.Broken tip is mdr-reportable.
Additional Manufacturer Narrative
On 24-apr-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a navistar thermocool: however, the device was damaged within the packaging.The device was found to have been cracked when the package was opened (with some wires exposed).A second device was used to complete the operation.There was no adverse event reported on patient.The device wasn¿t used on the patient.Device evaluation details: visual analysis revealed that the tip was broken at the peek housing section with exposed wires.The damage could be related to excessive force or use during the procedure, however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device number lot 30908249m and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of the 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 THERMOCOOL
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 16691500
• Report Number: 2029046-2023-00740
• Device Sequence Number: 12282072
• Product Code: OAD
• UDI-Device Identifier: 10846835008333
• UDI-Public: 10846835008333
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031
• 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
• Report Date (Section B): 05/18/2023

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: 09/11/2025
• Device Model Number: NI75TCBH
• Device Catalogue Number: NI75TCBH
• Device Lot Number: 30908249M
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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
• Patient Sex: Unknown