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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER

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MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number SENSH1828W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Perforation (2001); Vascular Dissection (3160)
Event Date 03/15/2022
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A sentrant sheath was used during a transcatheter aortic valve replacement (tavi) procedure.  it was reported that the procedure was performed by a certified physician with extensive experience. After releasing the valve, the patient began to experience hypotension. The anesthetist tried to reverse the condition with vasoactive drugs, at this time the echocardiogram physician reported having seen a pericardial effusion, after several maneuvers to reverse the hypotension without success, the operating physician placed a contrast pump revealing a major left ventricular dissection/perforation and patient suffered cardiac arrest. Cpr maneuvers were performed without great success, cardiac surgery team was called but also unsuccessful. After a few minutes, death was confirmed by the medical operator. Per physician, the dissection/perforation was most likely caused by the non-medtronic guide. The cause of death cannot be determined. There is no allegation of deficiency against the sentrant sheath. No additional clinical sequelae were reported and the patient expired.
 
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Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13888521
MDR Text Key287813386
Report Number9612164-2022-01152
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00643169792609
UDI-Public00643169792609
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K123990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/17/2022
Device Model NumberSENSH1828W
Device Catalogue NumberSENSH1828W
Device Lot Number00153507
Was Device Available for Evaluation? No
Date Returned to Manufacturer03/15/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/17/2020
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: 03/24/2022 Patient Sequence Number: 1
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