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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER

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ST. JUDE MEDICAL, INC. AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aortic Dissection (2491)
Event Type  Injury  
Manufacturer Narrative
Concomitant devices: brk needle, swartz introducer. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported aortic root puncture could not be conclusively determined.
 
Event Description
Related manufacturing ref: (b)(4). The following was published in the european society of cardiology in an article titled, "inadvertent transseptal puncture into the aortic root: the narrow edge between luck and catastrophe in interventional cardiology" by hao chen, et al. On 18 march 2019 regarding a multi-center study presenting experiences of unintentional aortic root puncture (arp) and clinical management occurring in 20 years of practicing transseptal puncture (tsp): all patients with arp were retrospectively collected from seven hospitals. Aortic root puncture was identified and classified regarding angiographical and intraoperative findings in cardiac surgery: (i) tsp from the right atrium (ra) to the non-coronary sinus (ncs), (ii) tsp from ra to the non-coronary sinutubular junction (stj), and (iii) tsp from ra to the ascending aorta (aa). A total of 24 patients with inadvertent arp were identified. In 19 patients, penetration of the aorta was accomplished by the inner dilator, in 5 patients by the complete sheath. Previous cardiac surgery had been performed in six patients. There were 13 ra-to-ncs punctures, 2 ra-to-stj punctures, and 9 ra-to-aa punctures. No cardiac tamponade (ct) occurred in patients with ra-to-ncs and ra-to-stj punctures. In 8 of 9 patients with ra-to-aa puncture, ct occurred immediately requiring urgent pericardiocentesis and surgical repair. Two patients died after surgical repair. In the 16 patients without surgical therapy, no shunt from the ar to the ra was observed 3 months after the procedure. The two deaths were due to vt electric storm 10 days post procedure and multi-organ failure and pneumonia 84 days post procedure. They were not attributed to the aortic root puncture.
 
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Brand NameAGILIS¿ INTRODUCER, UNKNOWN
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key9409710
MDR Text Key169207586
Report Number2182269-2019-00242
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
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? No
Event Location No Information
Date Manufacturer Received11/15/2019
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 Treatment Data
Date Received: 12/04/2019 Patient Sequence Number: 1
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