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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F INTRODUCER, CATHETER

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ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F INTRODUCER, CATHETER Back to Search Results
Model Number 407439
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiac Perforation (2513)
Event Date 07/25/2020
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 tamponade could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device. Further information regarding the event was requested but not received.
 
Event Description
Related manufacturer reference: 3008452825-2020-00416, 3008452825-2020-00417. During a ventricular tachycardia ablation procedure, a cardiac tamponade occurred. Following the transseptal puncture, when attempting the retro aortic technique, a cardiac tamponade was observed. The tamponade was confirmed by echocardiogram located at the left atrial appendage. It is unknown which device caused the tamponade. Defibrillation, cardiac massage and cardiac surgery were performed to treat the patient. The patient expired due to instable hemodynamics. There were no performance issues with any abbott device.
 
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Brand NameSWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER SL 1 CURVE, 63 CM LENGTH, 8F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL (AFD-PLYMOUTH)
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10430803
MDR Text Key203658997
Report Number3005334138-2020-00362
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734205634
UDI-Public05414734205634
Combination Product (y/n)N
Reporter Country CodeBR
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 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2022
Device Model Number407439
Device Catalogue Number407439
Device Lot Number7171327
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 Received09/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2019
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: 08/20/2020 Patient Sequence Number: 1
Treatment
BRK TRANSSEPTAL NEEDLE, 71 CM LENGTH; FLEXABILITY ABLATION CATHETER, BI-D, CURVE F-J
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