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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER

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W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number DSF2233
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pseudoaneurysm (2605)
Event Date 06/07/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, this patient underwent an endovascular treatment for an impending rupture of the descending thoracic aorta using gore® tag® conformable thoracic stent grafts with active control system and a gore® dryseal flex introducer sheath (dsf, 22fr). The final angiography showed no problem in the access vessels. The patient tolerated the procedure. On (b)(6) 2022, follow-up examination showed a pseudoaneurysm formation in the right external iliac artery which was the access vessel of initial procedure. On the same day, a gore® viabahn® endoprosthesis (8 mm x 5 cm) was implanted in the right external iliac artery. The patient tolerated the procedure. Reportedly, the diameter of the right external iliac artery was narrow (5. 7-6. 4 mm). According to the gore® dryseal flex introducer sheath sizing guide, the nominal outer diameter of the 22fr sheath is 8. 2 mm.
 
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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 Key14875694
MDR Text Key295051583
Report Number3007284313-2022-02010
Device Sequence Number1
Product Code DYB
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,Followup
Report Date 10/14/2022
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 NumberDSF2233
Device Catalogue NumberDSF2233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2022
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: 06/30/2022 Patient Sequence Number: 1
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