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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F INTRODUCER, CATHETER

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BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F INTRODUCER, CATHETER Back to Search Results
Model Number 10445
Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Event Date 10/07/2020
Event Type  Death  
Event Description
It was reported that hypotension, perforation, and death occurred. The patient was selected for a 27mm lotus edge valve implant and noted to have mild to moderate leaflet calcification. The patient was noted to have a gastrointestinal bleed prior to the procedure. A 15f isleeve introducer sheath was inserted into the right femoral artery and a 27mm lotus edge valve system was advanced. The lotus edge valve delivery catheter was hydrated with saline prior to insertion. The wet dry gauze technique was not used during advancement. Continuous flushing was done during insertion. During advancement, there was active back traction on the safari2 guidewire used. The 27mm lotus edge valve system was difficult to introduce and force was required to advance the lotus edge valve system through the 15f isleeve introducer sheath. A kink was noted in the 15 isleeve introducer sheath. The lotus edge valve was not advanced past the tip of the 15f isleeve introducer sheath before the kink was noted. The kink was near the proximal to mid portion of the 15f isleeve introducer sheath. The 27mm lotus edge valve system was removed through the 15f isleeve introducer sheath with a lot of back tension on the device. The 15f isleeve introducer sheath and the 27mm lotus edge valve system were removed from the patient separately. After removal, the patients blood pressure dropped significantly. Contrast was injected which showed that a perforation with extravasation was present. A covered stent was placed in the right iliac artery and chest compressions were started. The patients blood pressure and heart rhythm never returned to stable values and the patient died.
 
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Brand NameISLEEVE 15F
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 Key10769910
MDR Text Key214087863
Report Number2134265-2020-14434
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/03/2022
Device Model Number10445
Device Catalogue Number10445
Device Lot Number0025800691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2020
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: 11/02/2020 Patient Sequence Number: 1
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