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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 Problem Stenosis (2263)
Event Date 10/27/2020
Event Type  Injury  
Event Description
It was reported that vessel occlusion occurred. Procedure summary: the patient, with pre-existing aphasia, severe stenosis and severe calcification of the leaflets, was selected for an acurate neo2 valve implant. The acurate neo2 valve was prepped and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the instructions for use (ifu). Balloon valvuloplasty with a 24mm non-bsc balloon was performed, which caused the aortic annulus to rupture and the patient's blood pressure to decrease to 30 mmhg. Cardiac tamponade and ventricular fibrillation were observed, so advanced cardiac life support was initiated and pericardiocentesis was performed. During cardiac life support, the acurate neo2 tf ds was advanced into position through a 14f isleeve introducer sheath and the acurate neo2 valve was opened normally with deployment. Post-dilatation was performed. The patient's vitals became more stable and the physician's retrieved the 14f isleeve introducer sheath. Upon removal of the 14f isleeve introducer sheath, an occlusion of the right femoral artery was noticed. The vascular surgeon was called and vascular surgery was performed in the femoral artery. Patient status: post-procedure, the patient was stable and is recovering.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10891007
MDR Text Key217951120
Report Number2134265-2020-16175
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeLH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received11/01/2020
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: 11/24/2020 Patient Sequence Number: 1
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