SWARTZ? INTRODUCER, UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for SWARTZ? INTRODUCER, UNKNOWN manufactured by St. Jude Medical.

Event Text Entries

[186598549] The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was not reviewed as the batch number was not available. Based on the information received, the cause of the reported incident could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10


[186598550] Related manufacturing reference: 3005334138-2020-00135, 3005334138-2020-00138. During a cryoablation typical atrial flutter procedure a pericardial effusion occurred. The patient was hemodynamically stable for the duration of the procedure, however; after the case a pericardial effusion was diagnosed via echocardiography. The patient was transferred to surgically repair a perforation in the cavotricuspid isthmus. Following surgery the patient was stable. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005334138-2020-00134
MDR Report Key9888444
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-27
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 NameSWARTZ? INTRODUCER, UNKNOWN
Generic NameTRANSSEPTAL CATHETER INTRODUCER
Product CodeDYB
Date Received2020-03-27
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 2020-03-27

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