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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH+ INTRODUCER SET INTRODUCER, CATHETER

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EDWARDS LIFESCIENCES EDWARDS ESHEATH+ INTRODUCER SET INTRODUCER, CATHETER Back to Search Results
Model Number 914ESPA
Device Problems Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)
Patient Problem Unspecified Vascular Problem (4441)
Event Date 07/20/2022
Event Type  Injury  
Event Description
Per the field clinical specialist (fcs), during a tavr procedure using a 26mm sapien 3 ultra valve via transfemoral approach, when the sheath was removed, it was noted that the top of the sheath was split. It appeared that the material that normally expands, separated towards the top of the sheath. The dilator appeared to exit diagonally through the top of the sheath. The 14 fr sheath was inserted and tracked the delivery system and valve. The valve was deployed with no issues. The delivery system was removed, and the dilator was inserted back into the sheath. When the sheath was removed, the patient's pressure dropped. The physician performed an angiogram, a perforation in the common iliac artery was noted. The physician deployed two covered stents in the common iliac artery. Another angiogram was taken, and everything appeared fine. Patient was stable at the end of the procedure. It was noted that the patient had tortuous and calcified anatomy.
 
Manufacturer Narrative
Investigation is ongoing.
 
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Brand NameEDWARDS ESHEATH+ INTRODUCER SET
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
renee van dorne
1 edwards way
irvine, CA 92614
9492506385
MDR Report Key15209897
MDR Text Key297697530
Report Number2015691-2022-07256
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103215465
UDI-Public(01)00690103215465(17)240215(11)2202152164227613
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200258
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number914ESPA
Device Catalogue Number914ESPA
Device Lot Number64227613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2022
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: 08/11/2022 Patient Sequence Number: 1
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