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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY STEERABLE CATH. 6F, 1110-6-25-L
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ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY STEERABLE CATH. 6F, 1110-6-25-L Back to Search Results
Model Number 81104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Pericardial Effusion (3271)
Event Date 03/21/2014
Event Type  Injury  
Event Description
Related manufacturer ref 2030404-2014-00045, 3005188751-2014-00063, 3005188751-2014-00064, 3005188751-2014-00065, 3005188751-2014-00066, 3005188751-2014-00067.Following an atrial fibrillation procedure, a pericardial effusion occurred.Two transseptal punctures were performed with a brk transseptal needle and a swartz braided transseptal introducer and an agilis nxt introducer were advanced into the left atrium.An inquiry decapolar ep catheter was placed in the coronary sinus.A reflexion spiral ep catheter, an inquiry afocus ii ep catheter, and a tacticath ablation catheter were all used in the left atrium for mapping and ablation.Left and right wide area circumferential ablation (waca) were successfully performed around the pulmonary veins.The pt developed transient hypotension during the right waca but blood pressure returned to normal immediately.The procedure was completed and the pt converted to sinus rhythm.After the procedure, the pt became hypotensive and diaphoretic and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed, which stabilized the pt.The pt was discharged home a few days later and remained in sinus rhythm.There were no performances issues with any sjm device.
 
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Brand Name
INQUIRY STEERABLE CATH. 6F, 1110-6-25-L
Manufacturer (Section D)
ST. JUDE MEDICAL, COSTA RICA LTDA
alajuela
CS 
Manufacturer Contact
denise johnson, rn
177 east county rd b
st. paul, MN 55117
6517664470
MDR Report Key3784129
MDR Text Key4359026
Report Number3008452825-2014-00012
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K961924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/26/2014
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 Model Number81104
Device Lot Number4237621
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2014
Initial Date FDA Received04/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
INQUIRY AFOCUS II EP CATHETER (87008/4407706); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; BRK TRANSSEPTAL NEEDLE (407200/4368664); TACTICATH QUARTZ ABLATION CATHETER; REFLEXION SPIRAL EP CATHETER (402804/UNK); SUPREME EP QUADRIPOLAR CATHETER (401430/4402149); (PN-(B)(4)/25592); AGILIS NXT INTRODUCER (408310/4342988); (407356/4369928)
Patient Outcome(s) Required Intervention;
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