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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 Problems Arrhythmia (1721); Death (1802); Respiratory Failure (2484)
Event Date 01/08/2020
Event Type  Death  
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: 3008452825-2020-00015, 3005334138-2020-00019, 3008452825-2020-00016, 3008452825-2020-00018, 3008452825-2020-00019, 3005334138-2020-00020, 3005334138-2020-00021.During the mapping of a ventricular tachycardia ablation procedure, following mapping of the right and left ventricle, the patient experienced respiratory failure and pulseless electrical activity.An immediate cardiac massage was performed, without the restoration of natural heart contraction.There was no pericardial effusion visible with the intracardiac echo and the procedure was interrupted before the ablation.The patient expired.The cause of the respiratory failure and subsequent death 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 respiratory failure and subsequent death could not be conclusively determined.
 
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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 Key9590521
MDR Text Key175022916
Report Number3008452825-2020-00017
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 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model NumberG407209
Device Catalogue NumberG407209
Device Lot Number7190953
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADVISOR¿ HD GRID MAPPING CATHETER, SE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER (X2); SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER; ADVISOR¿ HD GRID MAPPING CATHETER, SE; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; FLEXABILITY¿ ABLATION CATHETER, SE; RESPONSE¿ ELECTROPHYSIOLOGY CATHETER (X2); SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; VIEWFLEX¿ XTRA ICE CATHETER
Patient Outcome(s) Death;
Patient Age69 YR
Patient Weight48
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