MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCFH
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter city: (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: pc-(b)(4).
Event or Problem Description
It was reported that a patient underwent an unspecified cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and blood ran back into the irrigation supply line.The medical team believed that there was pressure built up within the supply line, so much so that the irrigation tube came off.According to the nursing staff, the ablation catheter was flushed beforehand and everything was within their expected standard.The pump was probably also running while the catheter was in the patient.The physician then noticed the issue when they started to ablate.The physician saw blood running into the catheter.The catheter could no longer be flushed through.It is unknown if the nurse staff used haparin for the irrigation solution or if they used heparin in general, but the procedure was performed in the left atrium.So, according to standard guidelines, heparin should have been used.Additionally, a bwi generator was not used in this procedure--a competitor's generator and pump were used instead, therefore, it cannot be confirmed if the proper settings were used.No patient consequences were reported.
Additional Manufacturer Narrative
On 15-dec-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31116362m number, and no internal action related to the complaint was found during the review.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 11-jan-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an unspecified cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and blood ran back into the irrigation supply line.The medical team believed that there was pressure built up within the supply line, so much so that the irrigation tube came off.According to the nursing staff, the ablation catheter was flushed beforehand and everything was within their expected standard.The pump was probably also running while the catheter was in the patient.The physician then noticed the issue when they started to ablate.The physician saw blood running into the catheter.The catheter could no longer be flushed through.It is unknown if the nurse staff used heparin for the irrigation solution or if they used heparin in general, but the procedure was performed in the left atrium.So, according to standard guidelines, heparin should have been used.Additionally, a bwi generator was not used in this procedure--a competitor's generator and pump were used instead, therefore, it cannot be confirmed if the proper settings were used.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A pump and pressure gage test was performed and the device was found occluded.Further investigation revealed reddish material blocking the luer hub and irrigation holes.A manufacturing record evaluation was performed for the finished device 31116362m number, and no internal action related to the complaint was found during the review.The reddish material observed in the luer hub and dome could be related to the irrigation issue reported by the customer; therefore, the customer complaint 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.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: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• 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: 18240548
• Report Number: 2029046-2023-02792
• Device Sequence Number: 3176504
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/31/2024

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: 07/24/2026
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 31116362M
• 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: 11/04/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 01/11/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/09/2024; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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
• Patient Sex: Unknown