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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis (2100); No Code Available (3191)
Event Date 07/21/2018
Event Type  Injury  
Event Description
It was reported that the patient experienced major bleeding and thrombus. The patient was enrolled in the (b)(6) clinical study. Procedure summary: the patient underwent the transcatheter aortic valve implantation (tavi) procedure. A 14f isleeve introducer sheath was selected for use during the procedure and an acurate neo valve was implanted. On the same day major bleeding occurred at the access site. Vascular stenosis and hematoma related to the access site were also observed. There was suspicion of thrombus in the right anterior femoral superior artery that was treated with thromboendarterectomy. No further patient complications were reported.
 
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Brand NameISLEEVE 14F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10536790
MDR Text Key207113839
Report Number2134265-2020-12229
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number10445
Device Catalogue Number10445
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 Received08/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/15/2020 Patient Sequence Number: 1
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