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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F INTRODUCER, CATHETER Back to Search Results
Model Number 407453
Device Problem Gas Leak (2946)
Patient Problem ST Segment Elevation (2059)
Event Date 06/20/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
Related manufacturing reference: 3005334138-2019-00355. During a redo atrial fibrillation ablation procedure st segment elevation occurred. Following transseptal puncture, guided by x-ray and echocardiography imaging, contrast injection revealed the sheath in the transverse pericardial space instead of the left atrium. Blood pressure and oxygen saturation levels remained stable when this was observed but the electrocardiogram showed st segment elevation which resolved on its own. The procedure was continued and a second transseptal puncture was performed. While confirming the sheath was in the left atrium via contrast injection, st segment elevation recurred. The patient then became hypotensive, oxygen saturation levels declined and the patient went into atrioventricular node block along with a ventricular tachycardia episode. The procedure was stopped and the st elevation resolved without intervention and adrenaline and oxygen was administered to recover the heart. Coronary and cerebral angiography confirmed there was no air embolism following the symptoms but transesophageal images indicated small air bubbles in the left cavities before st elevation had occurred. The patient left the or in stable condition.
 
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Brand NameSWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F
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 Key8771421
MDR Text Key150402515
Report Number3005334138-2019-00356
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 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number407453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Yes
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: 07/09/2019 Patient Sequence Number: 1
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