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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¿, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER
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ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER Back to Search Results
Model Number 407452
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 01/14/2019
Type of Reportable Event Serious Injury
Additional 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 pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device. .
 
Event or Problem Description
Related manufacturing ref: 3008452825-2019-00041, 3008452825-2019-00042, 3008452825-2019-00043, 3008452825-2019-00044, 3005334138-2019-00050, 3005334138-2019-00051, 3008452825-2019-00045.Following a pulmonary vein isolation procedure, a pericardial effusion was noted via echocardiography.A pericardiocentesis was performed to stabilize the patient.No patient symptoms were noted throughout the procedure and there were no performance issues with any abbott device.
 
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Brand Name
SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 81 CM LENGTH, 8.5F
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key8304822
Report Number3005334138-2019-00052
Device Sequence Number13491267
Product Code DYB
UDI-Device Identifier05414734205764
UDI-Public05414734205764
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K052644
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date02/28/2021
Device Model Number407452
Device Lot Number6366625
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/14/2019
Initial Report FDA Received Date02/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ADVISOR¿ FL, CIRCULAR MAPPING CATHETER; AGILIS¿ NXT STEERABLE INTRODUCER; BRK¿ XS TRANSSEPTAL NEEDLE; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; SWARTZ¿ BRAIDED INTRODUCER; SWARTZ¿ BRAIDED INTRODUCER; TACTICATH¿ CONTACT FORCE CATHETER, SENSOR ENABLED¿
Outcome Attributed to Adverse Event Required Intervention;
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