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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

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ST. JUDE MEDICAL, COSTA RICA LTDA BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH Back to Search Results
Model Number G407208
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 01/27/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.The cause of the reported cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
 
Event Description
Related manufacturing ref: 9680001-2017-00014.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Three hours post procedure, the patient became hypotensive and an echocardiogram revealed an effusion.A pericardiocentesis was performed and the patient was transferred to the icu and was transfused which stabilized the patient.There were no performance issues with any abbott devices.
 
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Brand Name
BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Type of Device
TRANSSEPTAL NEEDLE
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
Manufacturer (Section G)
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
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6357249
MDR Text Key68299724
Report Number3008452825-2017-00025
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K072278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 01/27/2017
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 Date09/30/2019
Device Model NumberG407208
Device Lot Number5674403
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2017
Initial Date FDA Received02/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AGILIS NXT INTRODUCER; SWARTZ BRAIDED INTRODUCER; TACTICATH ABLATION CATHETER
Patient Outcome(s) Required Intervention;
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