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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR
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ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR Back to Search Results
Model Number G407209
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 10/17/2019
Event Type  Injury  
Manufacturer Narrative
The results / method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
 
Event Description
Related manufacturer reference: 3008452825-2019-00533, 2182269-2019-00187, 3008452825-2019-00535, 3005334138-2019-00588, 3008452825-2019-00536.During an atrial fibrillation procedure, a pericardial effusion occurred.An isolation of the pulmonary veins and an ablation of the mitral isthmus was performed with several radiofrequency deliveries on the coronary sinus.Following the procedure, the patient became hypotensive and experienced chest pain in the recovery room.A pericardial effusion was confirmed with ultrasound and a pericardiocentesis was performed to stabilize the patient.The cause and location of the pericardial effusion is unknown.There were no performance issues with any abbott device.
 
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.
 
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Brand Name
BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Type of Device
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 Key9240534
MDR Text Key164131749
Report Number3008452825-2019-00534
Device Sequence Number1
Product Code DRC
UDI-Device Identifier05414734205184
UDI-Public05414734205184
Combination Product (y/n)N
PMA/PMN Number
K122587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/15/2019
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
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model NumberG407209
Device Lot Number7121697
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/17/2019
Initial Date FDA Received10/25/2019
Supplement Dates Manufacturer Received11/01/2019
Supplement Dates FDA Received11/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AGILIS¿ NXT STEERABLE INTRODUCER; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; REFLEXION¿ SPIRAL BI-DIRECTIONAL CATHETER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
Patient Outcome(s) Other;
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