FLEXABILITY ABLATION CATHETER-UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for FLEXABILITY ABLATION CATHETER-UNKNOWN manufactured by St. Jude Medical.

Event Text Entries

[182782784] Concomitant devices: therapy cool path duo catheter, event date unknown. The results of the investigation are inconclusive since the device was not returned for analysis. Review of the device history record was not possible as the lot number is unknown. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[182782785] Related manufacturer reference number: 2030404-2020-00018. The following was published in the international journal of cardiology in an article titled? Elongation of the high right atrium to coronary sinus conduction time predicts the recurrence of atrial fibrillation after radiofrequency catheter ablation? By kanemaru y, arima y, kaikita k, et al. , 18 november 2019. ? The impact of intra-atrial conduction delay on the recurrence of atrial tachyarrhythmia after radio frequency catheter ablation (rfca) has not been fully elucidated. In this study, 155 af patients who were in sinus rhythm at the start of rfca were analyzed at the kumamoto university hospital from january 2011 to march 2017. The conduction time from the onset of the earliest atrial electrogram at the high right atrium (hra) to the end of the latest electrogram at the coronary sinus (cs) during sinus rhythm was defined as hra-cs conduction time. Pulmonary vein isolation (pvi) was performed followed by linear roof lesion and complex fractionated atrial electrogram (cfae) ablation until af termination. Of the 155 patients, four experienced esophageal injuries. The conclusion was that the hra-cs conduction time was the primary influencing factor that predicted the recurrence of atrial tachyarrhythmia after catheter ablation. (https://doi. Org/10. 1016/j. Ijcard. 2019. 10. 044).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005334138-2020-00101
MDR Report Key9812314
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-03-10
Date Mfgr Received2020-02-17
Date Added to Maude2020-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXABILITY ABLATION CATHETER-UNKNOWN
Generic NameCATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Product CodeOAD
Date Received2020-03-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-10

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