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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1 TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR
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ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1 TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR Back to Search Results
Model Number 407207
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 09/16/2020
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 remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
 
Event or Problem Description
Related manufacturing ref: 3008452825-2020-00522, 3005334138-2020-00469, 3008452825-2020-00523.During the atrial fibrillation ablation procedure, a pericardial effusion was noted following transseptal puncture and collection of left atrium points.An ice catheter confirmed the effusion and a pericardiocentesis was performed to stabilize the patient.
 
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Brand Name
BRK-1 TRANSSEPTAL NEEDLE, 98 CM LENGTH
Common Device Name
TROCAR
Manufacturer (Section D)
ST. JUDE MEDICAL, COSTA RICA LTDA
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key10642540
Report Number3008452825-2020-00524
Device Sequence Number2604654
Product Code DRC
UDI-Device Identifier05414734205177
UDI-Public05414734205177
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K072278
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) 10/07/2020
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 Date03/31/2022
Device Model Number407207
Device Catalogue Number407207
Device Lot Number6970773
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 09/16/2020
Initial Report FDA Received Date10/07/2020
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
AGILIS¿ NXT INTRODUCER; BRK-1¿ TRANSSEPTAL NEEDLE; SWARTZ¿ BRAIDED INTRODUCER
Outcome Attributed to Adverse Event Required Intervention;
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