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

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.

• Brand Name: ENSITE¿ VELOCITY¿ CARDIAC MAPPING SYSTEM
• Type of Device: COMPUTER, 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 Key: 5656152
• MDR Text Key: 45214299
• Report Number: 2184149-2016-00005
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 88