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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiac Perforation (2513)
Event Date 11/16/2020
Event Type  Death  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. 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.
 
Event Description
During the ventricular tachycardia ablation procedure, the patient had a cardiac perforation and subsequently died. An hd grid was inserted through a sl1 introducer. A transseptal puncture was performed using a non-abbott guidewire and the sheath passed successfully into what was believed to be the left pulmonary vein, although the location was not certain after switching the guidewires out for the sheath. Resistance was felt while trying to cross into the mitral valve. The sheath was retracted and advanced again, and it was possible it perforated the left atrial appendage at this time. The hd grid did not move where expected, and it became clear during mapping that it was in the pericardial space. An effusion was identified via transthoracic echocardiography, a pericardiocentesis was performed on the table and the patient was prepped for surgery to repair the perforation from the sheath. The bleeding later stabilized, and no surgery was needed. The patient died overnight from pulseless electrical activity. There were no performance issues with any abbott device.
 
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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 Key10988260
MDR Text Key220817372
Report Number3005334138-2020-00581
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734205771
UDI-Public(01)05414734205771(10)7545008(17)230531
Combination Product (y/n)N
Reporter Country CodeAS
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number407453
Device Catalogue Number407453
Device Lot Number7545008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 12/10/2020 Patient Sequence Number: 1
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