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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 9610ES16
Device Problems Nonstandard Device (1420); Particulates (1451)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is in progress. A supplemental report will be submitted.
 
Event Description
Edwards received notification from our affiliate in (b)(6). As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve. During preparation of the esheath, a small defect was noted and some particles of the light-blue material came out of the package. It seemed that the esheath was not finished up to the top during manufacturing. Therefore, the esheath was not used. It was decided to open a second kit to continue with the procedure. The procedure was completed successfully. The patient final outcome was good. Per pre-decontamination evaluation, 2 areas of unknown clear material stain were noted on the esheath. There was no blue material or any other material observed in the returned packing.
 
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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 Key13426247
MDR Text Key284979179
Report Number2015691-2022-03755
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00690103193244
UDI-Public(01)00690103193244(17)230809(10)63935298
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 Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9610ES16
Device Catalogue NumberN/A
Device Lot Number63935298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/09/2021
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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