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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS EXPANDABLE INTRODUCER INTRODUCER, CATHETER Back to Search Results
Model Number 9610ES14
Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Patient Problem Unspecified Vascular Problem (4441)
Event Date 06/29/2022
Event Type  Injury  
Manufacturer Narrative
Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available.
 
Event Description
As reported by our edwards affiliate in france, during a transfemoral tavr procedure, some difficulties were encountered during the insertion of a 14fr esheath. As the sheath was being inserted, the threads of the closing system (4 threads / 2 systems) were moved. Following sheath placement, a 20mm sapien 3 valve was successfully implanted. Following the removal of the sheath, the closure threads could not be used to close the artery. Two more closure devices were used. During the attempt to remove the lost threads with guide, the artery was torn. Surgical repair of the artery was performed. At the time of the report, the patient was in stable condition. The valve remains implanted in the patient.
 
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Brand NameEDWARDS EXPANDABLE 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 Key15042097
MDR Text Key296065792
Report Number2015691-2022-06825
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number9610ES14
Device Lot Number64162397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2022
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: 07/18/2022 Patient Sequence Number: 1
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