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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 01/25/2024
Event Type  malfunction  
Event Description
It was reported the tip tore in an atypical manner.Procedure summary: during a transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a transfemoral approach.The mildly calcified native aortic annulus measured 23.3mm in diameter.A 14f isleeve introducer sheath was placed and a safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 20mm non boston scientific (bsc) balloon catheter in accordance with the instructions for use (ifu).A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.Commissural alignment via array technique was performed.The acurate neo2 tf ds was advanced and the acurate neo2 valve was released at the intended location.Event summary: at the conclusion of the procedure, the 14f isleeve introducer sheath was removed from the patient and it was observed the tip of the 14f isleeve introducer sheath had torn in an atypical manner.Patient status: no patient complications were reported.
 
Event Description
It was reported the tip tore in an atypical manner.Procedure summary: during a transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a transfemoral approach.The mildly calcified native aortic annulus measured 23.3mm in diameter.A 14f isleeve introducer sheath was placed and a safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 20mm non boston scientific (bsc) balloon catheter in accordance with the instructions for use (ifu).A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.Commissural alignment via array technique was performed.The acurate neo2 tf ds was advanced and the acurate neo2 valve was released at the intended location.Event summary: at the conclusion of the procedure, the 14f isleeve introducer sheath was removed from the patient and it was observed the tip of the 14f isleeve introducer sheath had torn in an atypical manner.Patient status: no patient complications were reported.
 
Manufacturer Narrative
H3 device evaluated by mfr: a single photographic image of the 14f isleeve introducer sheath was provided to aid in the investigation and was analyzed by a bsc quality technician.The photograph depicted the material at the tip of the 14f isleeve introducer sheath as torn and upraised.Analysis of the photographic image confirmed the reported tip damage.
 
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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 Key18607865
MDR Text Key334806076
Report Number2124215-2024-04225
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0032059395
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2024
Initial Date FDA Received01/30/2024
Supplement Dates Manufacturer Received02/20/2024
Supplement Dates FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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