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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER INTRODUCER, CATHETER Back to Search Results
Model Number 9610ES14
Device Problem Difficult to Advance (2920)
Patient Problem Obstruction/Occlusion (2422)
Event Date 03/23/2022
Event Type  Injury  
Manufacturer Narrative
Investigation is still ongoing.
 
Event Description
As reported by an edwards (b)(4) affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, there were difficulties inserting the valve through the esheath, and a lot of push force had to be used. Upon removal of the delivery system and esheath, it was noted that the devices were very angled and curved due to the patient anatomy. A femoral angiogram showed vessel occlusion at the access site where the non-edwards closure device was used. The team decided to crossed with a wire and a balloon was used to open the vessel, and good flow was achieved. There was no device damage or edwards device malfunction. The curve was due to the patient anatomy. Per medical opinion, the perceived root was a combination of calcium in common femoral artery (cfa), high puncture, and the non-edwards closure device with a combination of high push force used to pass the valve through the e-sheath. The patient was doing well, and the procedure went well with a good result.
 
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Brand NameEDWARDS ESHEATH INTRODUCER
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 Key14119456
MDR Text Key289347677
Report Number2015691-2022-05155
Device Sequence Number1
Product Code DYB
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9610ES14
Device Lot Number64188729
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2021
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: 04/15/2022 Patient Sequence Number: 1
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