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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 Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2024
Event Type  malfunction  
Event Description
It was reported that the tip of the 14f isleeve introducer sheath tore in an atypical manner.Procedure summary the native aortic annulus was 25.8mm in diameter with moderate calcification.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was inserted.A safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with two (2) inflations of a 23mm non-bsc balloon catheter in accordance with the instructions for use (ifu).A large size acurate neo2 valve was loaded onto an acurate neo2 transfemoral delivery system (tf ds) in accordance with the ifu.The acurate neo2 tf ds was advanced into position and the acurate neo2 valve was successfully implanted to treat the native aortic annulus.The acurate neo2 tf ds was removed from the patient with no issues noted.While the physician was removing the 14f isleeve introducer sheath it was noted that the tip of the 14f isleeve introducer sheath tore in an atypical manner.Patient status: no patient consequences were reported.
 
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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 Key19217102
MDR Text Key341461143
Report Number2124215-2024-24650
Device Sequence Number1
Product Code DYB
UDI-Device Identifier08714729950660
UDI-Public08714729950660
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
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 Number0033055284
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient SexFemale
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