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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Event Date 04/14/2016
Event Type  Injury  
Event Description
During a pulmonary vein isolation, a pericardial effusion occurred. Transseptal access was obtained through the patent foramen ovale and mapping was performed with the spiral and ablation catheters. The left inferior pulmonary vein (lipv) was isolated and an extended break in the procedure was taken. Following this break, difficulty was encountered reaching the lateral inferior portion of the lspv and a geometry shift was noted; enguide alignment was used to match the catheter to its shadow. Ablation was continued on the left pulmonary veins with no issues; however, near the conclusion of ablation, the patient became hypotensive. An ice catheter revealed a pericardial effusion, for which vasopressors were administered to maintain blood pressure. After isolation of the right superior pulmonary vein, the procedure was terminated and a pericardiocentesis was performed to stabilize the patient.
 
Manufacturer Narrative
(b)(4). The (b)(4) study was returned for evaluation. Review of the study revealed the reported geometry shift. Only a single instance of respiration data was collected and this was performed when two catheters were inserted. The velocity cardiac mapping system instructions for use states: "if a new electrode or catheter is defined after respiration data collection completes, the user should manually recollect respiration compensation data. ". No further data was collected after two additional catheters were introduced into the patient. During the study, the positional reference was set to the system reference. The single recorded segment did not capture the movement of the catheters indicating the geometry shift between autosegments. The device history record for the above-referenced product was unable to be reviewed since the serial number is unknown. The cause of this catheter movement cannot be determined.
 
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Brand NameENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key5656152
MDR Text Key45214299
Report Number2184149-2016-00005
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/16/2016 Patient Sequence Number: 1
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