Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W. L. GORE ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER Back to Search Results
Model Number DSF1633
Device Problems Leak/Splash (1354); Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 02/27/2023
Event Type  malfunction  
Event Description
During thrombectomy and angioplasty of right femoral vein the dry seal that is intended to prevent any backflow or leakage of blood from the access site failed.Cath lab tech flushed the sheath to set up dry seal per protocol before it was inserted by the physician.Once the device was in the patient, the physician was able to advance the penumbra flash thrombectomy catheter through the sheath and perform two passes removing some obstructing clots.However, the staff at the table noticed the dry seal was leaking around the sheath indicating the dry seal was malfunctioning.In addition, the physician reported having difficulty maneuvering the catheter inside the sheath.The leaking could not be stopped so sheath device was removed.Other device was used to successfully complete the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GORE DRYSEAL FLEX INTRODUCER SHEATH
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
W. L. GORE ASSOCIATES, INC.
32360 n. north valley parkway
phoenix AZ 85085
MDR Report Key16655048
MDR Text Key312438716
Report Number16655048
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDSF1633
Device Catalogue NumberDSF1633
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2023
Date Report to Manufacturer03/31/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/31/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age12775 DA
-
-