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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F INTRODUCER, CATHETER Back to Search Results
Model Number 407451
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem ST Segment Elevation (2059)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative
Investigation results will be provided in the final report.
 
Event Description
During an atrial fibrillation procedure the ecg showed st elevation when a transseptal puncture was performed. It was believed that air entered through the sheath. After the transseptal puncture, a guide wire and catheter were introduced to place the sheath into the pulmonary vein, and a contrast bolus was delivered to perform angiography. After this sequence, st elevation occurred. The patient was treated with noradrenaline, pacing, and nitroglycerin. After approximately 30 minutes, the patient stabilized.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8754595
MDR Text Key149832053
Report Number3005334138-2019-00348
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K052644
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Model Number407451
Device Lot Number7009535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/02/2019 Patient Sequence Number: 1
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