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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. FLEXCATH ADVANCE CATHETER, STEERABLE

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MEDTRONIC, INC. FLEXCATH ADVANCE CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
Event Type  malfunction  
Event Description
Dilator unable to seat in catheter, not in patient's body, no harm or injury to pt. Utilized a new sheath w/o issues.
 
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Brand NameFLEXCATH ADVANCE
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key13440319
MDR Text Key285063816
Report Number13440319
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/01/2022,02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Lot Number0010869891
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2022
Event Location Hospital
Date Report to Manufacturer02/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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