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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRAIDED SWARTZ INTRODUCER, SL0. 8F, 63CM INTRODUCER, CATHETER

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ST. JUDE MEDICAL BRAIDED SWARTZ INTRODUCER, SL0. 8F, 63CM INTRODUCER, CATHETER Back to Search Results
Model Number G407371
Device Problem Gas Leak (2946)
Patient Problems ST Segment Elevation (2059); Embolism/Embolus (4438)
Event Date 12/21/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
During a pulmonary vein isolation procedure for atrial fibrillation, an air leak and st elevation occurred. When starting to deliver rf energy with the ablation catheter after drawing left atrium geometry with an optima catheter on ensite, the patients blood pressure decreased, st segment rose at the 12 leads electrogram and ventricular tachycardia was intermittently induced to the patient. Cardioversion was performed a few times and cardiac massage was performed and the patient was kept awake. An angiocardiography was performed which confirmed no spasm or air in the right artery. After the blood pressure returned to normal, st segment returned to normal with no treatment or drugs and the pulmonary vein isolation was performed with no adverse consequences to the patient. At the end of the procedure, after removing the catheter from the sheath, air was aspirated into a syringe that connected to the extension port of the sheath.
 
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Brand NameBRAIDED SWARTZ INTRODUCER, SL0. 8F, 63CM
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 Key11065451
MDR Text Key223421489
Report Number3005334138-2020-00647
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
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 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG407371
Device Lot Number7641204
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/27/2020
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: 12/23/2020 Patient Sequence Number: 1
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