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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D; CARDIAC ABLATION PERCUTANEOUS CATHETER

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ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number A701124
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolus (1830); Hematoma (1884); Cardiac Perforation (2513)
Event Date 06/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported cardiac perforation, hematoma, embolus, and thrombosis could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
 
Event Description
Related manufacturer reference: 9680001-2017-00052, 2030404-2017-00028, 3005334138-2017-00092.The following was published in the journal of arrhythmia 33 (2017) 167-171, page 168, 169 and 170.¿the patients were divided into 2 groups, rmn and a man group.A total of 443 patients were included in the study.The rmn group consisted of 214 patients and man group consisted of 229 patients.After pre-procedural transesophageal echocardiograms to exclude left atrial clot, vascular access was obtained via the femoral veins, and multipolar catheters were placed in the coronary sinus and selectively in the right ventricle.Transseptal punctures were performed fluoroscopically and depending on the physician¿s preference, with intracardiac ultrasound guidance.Sw or sl1 sheaths (st jude medical inc., (b)(4)) were advanced into the left atrium.Heparin was administered upon left atrial access and an activated clotting time of 250-400s was the target for anticoagulation throughout the procedure.For the man group, ablation was done by standard technique utilizing flexibility, tacticath and inquiry optima plus catheters.Both groups had one patient each where the development of pericardia effusions necessitated mid-procedural abandonment, for which they were also considered failed procedures.Among patients in the man group, 2 patients developed significant pericardia effusions during ablation and required emergency pericardiocentesis.The third patient who had tamponade suffered right atrial perforation during difficult trans-septal puncture and was not catheter related.Two patients in the man group suffered significant hematomas prolonging inpatient stay because of difficult groin access, 1 patient had an intra-procedural air embolism and another patient had a deep vein thrombosis post procedure.The other documented complications included post procedure stroke, access site bleeding with partial thrombosis, and a pulmonary venous infarction from an occluded lingular branch of the pulmonary vein in a patient that presented with hemoptysis.".
 
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Brand Name
FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6745184
MDR Text Key81091872
Report Number3005334138-2017-00091
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
P110016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/15/2018
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 NumberA701124
Device Catalogue NumberA701124
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2017
Initial Date FDA Received07/26/2017
Supplement Dates Manufacturer Received01/16/2018
Supplement Dates FDA Received02/15/2018
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 OPTIMA CATHETER; SWARTZ INTRODUCER; TACTICATH CATHETER
Patient Outcome(s) Required Intervention;
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