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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS INTRODUCER, CATHETER

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EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS INTRODUCER, CATHETER Back to Search Results
Model Number 916ESPA
Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2022
Event Type  malfunction  
Event Description
As reported, during a transcatheter aortic valve replacement procedure using a 26mm sapien 3 ultra valve via subclavian approach, the tip of the sheath was noted to be shredded upon removal. A small kink was noted on the mid shaft.
 
Manufacturer Narrative
Device not returned. Investigation is ongoing.
 
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Brand NameEDWARDS ESHEATH PLUS
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 Key15190961
MDR Text Key302059090
Report Number2015691-2022-07223
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103215472
UDI-Public(01)00690103215472(17)240223(11)2202232164237966
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number916ESPA
Device Lot Number64237966
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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