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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER, CATHETER

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EDWARDS LIFESCIENCES, PR INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number I300F85
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
As reported, during use in patient with this introducer placed in the right jugular vein, there was blood backing up from the sheath and leaking from the hemostasis valve. The quantity of blood loss was insignificant and there was no medication loss. The issue was solved replacing the introducer using the same insertion site but new stick (removing all the components and starting the process from the beginning). There was no allegation of patient injury. Patient demographics unable to be obtained. The device was available for evaluation.
 
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results. The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance. All process parameters were met and inspections passed successfully.
 
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Brand NameINTRO-FLEX PERCUTANEOUS SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key13116734
MDR Text Key283236822
Report Number2015691-2021-07111
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberI300F85
Device Lot Number63675253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2021
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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