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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 UNK-CV-SR-SENTRANT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rupture (2208); Vascular Dissection (3160)
Event Date 06/15/2022
Event Type  Injury  
Event Description
A sentrant sheath was used during a tavr procedure.   it was reported during the index procedure while wound closure was being performed, no flow was confirmed between the left common iliac artery and the external iliac artery, indicating dissection. It is believed the aneurysm ruptured. It is unknown at what stage of the procedure the dissection occurred. The introducer sheath used in this case was a medtronic sentrant (18 fr).   a non-mdt and other vascular stents were placed while checking with ivus. The blood flow was confirmed by angiography and the procedure was completed. No cause of the event as per the physician was provided.   no additional clinical sequalae was provided and the patient will be monitored.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key14775826
MDR Text Key294521997
Report Number9612164-2022-02373
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
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 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK-CV-SR-SENTRANT
Device Catalogue NumberUNK-CV-SR-SENTRANT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/22/2022 Patient Sequence Number: 1
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