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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER Back to Search Results
Model Number 10445
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2024
Event Type  malfunction  
Event Description
It was reported that the tip tore in an atypical manner.The femoral anatomy contained mild calcium, mild stenosis, and mild tortuosity.A transcatheter aortic valve implant procedure was being performed and a 14f isleeve introducer sheath was utilized for femoral access.No abnormalities or resistance occurred during insertion or retrieval of the 14f isleeve introducer sheath.After removal of the 14f isleeve introducer sheath from the patient's anatomy, it was observed that the tip had tore in an atypical manner with a portion of the tip was hanging off.There were no patient complications.
 
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Brand Name
ISLEEVE 14F
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19201438
MDR Text Key341264320
Report Number2124215-2024-25450
Device Sequence Number1
Product Code DYB
UDI-Device Identifier08714729950660
UDI-Public08714729950660
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10445
Device Catalogue Number10445
Device Lot Number0033086157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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