MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTRO1PHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCCH

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Paresis (1998)

Event Date 06/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: takamatsu s, tachibana m, ii n, hasui y, matsumoto k, banba k.Proper use of fentanyl facilitates anesthesia during pulmonary vein isolation.Heart vessels.2022 jun;37(6):1034-1043.Doi: 10.1007/s00380-021-02001-y.Epub 2022 jan 7.Pmid: 34993585.Objective/methods/study data: the authors aimed to clarify the optimal fentanyl dosage and timing of administration for the anesthetic management during pvi.A total of 364 patients with atrial fibrillation (af) who underwent pvi at our institution between june 2017 and october 2020 were recruited.All patients were anesthetized with propofol for induction and maintenance under controlled ventilation via the supraglottic airway without neuromuscular blocking drugs.Among them, 234 patients received less frequent injections (group 1) and 130 received a scheduled injection of 50 mg of fentanyl (group 2) in addition to propofol during pvi.The mean patient age was 67.2 years, and 69% were male.The total propofol dose was significantly lower in group 2 than in group 1 (17.0¿±¿5.2 mg/kg vs.19.0¿±¿5.5 mg/kg, p¿<¿0.01).The loading dose and frequency of additional propofol were also significantly lower in group 2 than in group 1.The procedure time was significantly shorter in group 2 than in group 1 (119¿±¿36 min vs.132¿±¿31 min, p¿<¿0.01).In groups 1 and 2, pvi was successfully completed in all cases; however, six of the total patients experienced complications.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navister thermocool smarttouch sf catheter.Other biosense webster devices that were also used in this study: lasso, carto 3 non-biosense webster devices that were also used in this study: temperature probe( fe-po et watcher, fkd-sp-3, fukuda denshi).Noted that qty 1 patient experienced a hematoma at the puncture site (anatomical location such as atrial septal or femoral vein is not provided) and is associated with a puncture device.The article does not identify the puncture device, and the manufacturer of the puncture device is not discussed.Adverse event(s) and provided interventions (possibly associated with the cardiac ablation catheter) : qty 1 symptomatic cerebral infarction - no specific information provided regarding interventions and patient completely recovered within a week after ablation.Qty 2 prolonged phrenic nerve paralysis - no specific information provided regarding interventions and patients fully recovered within 3 months.Qty 2 gastric hypomotility - no specific information provided regarding interventions and patients fully recovered within 3 months.

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: takamatsu s, tachibana m, ii n, hasui y, matsumoto k, banba k.Proper use of fentanyl facilitates anesthesia during pulmonary vein isolation.Heart vessels.2022 jun;37(6):1034-1043.Doi: 10.1007/s00380-021-02001-y.Epub 2022 jan 7.Pmid: 34993585.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTRO1PHYSIOLOGY CATHETER
• Type of Device: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15316210
• MDR Text Key: 298867135
• Report Number: 2029046-2022-02027
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008357
• UDI-Public: 10846835008357
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NI75TCCH
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening