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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR
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ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR Back to Search Results
Model Number G407211
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 01/15/2019
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 manufacturer reference: 3008452825-2019-00031, 3008452825-2019-00032, 3008452825-2019-00033, 3005334138-2019-00048.During a pulmonary vein isolation procedure, a pericardial effusion occurred.Following the ablation, at the end of the procedure, the patient became hypotensive.An ultrasound confirmed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.The location of the effusion remains unknown.There were no performance issues with any abbott device during the procedure.
 
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Brand Name
BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
Common Device Name
TROCAR
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key8296273
Report Number3008452825-2019-00034
Device Sequence Number16679694
Product Code DRC
UDI-Device Identifier05414734205153
UDI-Public05414734205153
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K122587
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) 02/01/2019
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 Date11/30/2021
Device Model NumberG407211
Device Lot Number6761242
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 01/15/2019
Initial Report FDA Received Date02/01/2019
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 SE; AGILIS¿ NXT STEERABLE INTRODUCER; FLEXABILITY¿ ABLATION CATHETER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
Outcome Attributed to Adverse Event Other; Required Intervention;
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