• 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 DSF2433
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 06/02/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, this patient underwent an endovascular treatment of a thoracic aortic aneurysm using gore® tag® conformable thoracic stent graft with active control system. A gore® dryseal flex introducer sheath (24fr) was inserted from the right femoral artery without any resistance. After the stent graft was implanted, when the sheath was removed, the blood pressure decreased and right external iliac artery rupture was observed. A gore® excluder® aaa endoprosthesis contralateral leg component was implanted from the common iliac artery to the external iliac artery. Blood pressure was recovered. The blood flow of the internal iliac artery was preserved. The physician stated there was no resistance when the sheath was inserted. Reportedly, the patient access vessel was 9 mm, but it was stenotic.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORE® DRYSEAL FLEX INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
douglas rhodes
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14875541
MDR Text Key295048259
Report Number3007284313-2022-02007
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630950
UDI-Public00733132630950
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2433
Device Catalogue NumberDSF2433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2020
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: 06/30/2022 Patient Sequence Number: 1
-
-