• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Intimal Dissection (1333); Occlusion (1984); Injury (2348); Blood Loss (2597); Pseudoaneurysm (2605)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative
Medtronic received the following information obtained from the journal article entitled; access site complications after transfemoral aortic valve implantation - a comparison of manta and proglide pavel hoffmann , ahmed al-ani, thomas von lueder, jenny hoffmann, peter majak, ove hagen, helga loose, nils einar kløw and anders opdahl; exact event dates unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A sentrant sheath was used in the endovascular treatment of patients for tavi valve implantation. Adverse events - occlusion, bleeding, pseudoaneurysm, flow limiting stenosis or dissection, intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key8226271
MDR Text Key132357858
Report Number2953200-2019-00052
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K123990
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 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
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: 01/08/2019 Patient Sequence Number: 1
-
-