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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK; TROCAR
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ST. JUDE MEDICAL BRK; TROCAR Back to Search Results
Catalog Number G408324
Device Problem Unintended Movement (3026)
Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Event Date 02/14/2018
Event Type  Injury  
Event Description
It was reported that during a ventricular tachycardia procedure, the diagnostic catheter was placed and a transseptal puncture was attempted twice.The lntracardiac echocardiography {ice) catheter was inserted to attempt the puncture and that is when the effusion was found.They got a full echo and did not think it was a large effusion so they proceeded with the procedure.Post procedure, when the blood pressure dropped more, ice showed a larger effusion.The medical intervention provided was a pericardiocentesis and 400+ ml of fluid were removed.The patient's condition was stable.Additional information received stated that the physician's opinion regarding the cause of the adverse event was that it was procedure-related.It was noted that the injury occurred during transseptal phase, as transseptal puncture was attempted twice using only fluoroscopy.The transseptal puncture was performed with a st.Jude medical brk-1 xs transseptal needle and a stryker reprocessed st.Jude medical agilis large curl sheath (ref#: g408324 lot#: 3461044 sn:(b)(6).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
BRK
Type of Device
TROCAR
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17523272
MDR Text Key321044550
Report NumberMW5130220
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Catalogue NumberG408324
Device Lot Number3461044
Patient Sequence Number1
Treatment
STRYKER REPROCESSED ST. JUDE MEDICAL AGILIS LARGE
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