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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 DSF1633
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Perforation of Vessels (2135)
Event Date 08/05/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿adequate vessel access is required to introduce the sheath into the vasculature. Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal. If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result. ¿.
 
Event Description
On (b)(6) 2022, the patient underwent endovascular treatment of bilateral iliac artery aneurysms using a gore® viabahn® vbx balloon expandable endoprosthesis, and a gore® dryseal flex introducer sheath (dsf) as an accessory in the procedure. According to the report, the left external iliac artery was ruptured by a non-gore manufactured device during the procedure. To treat the vessel rupture, a 16fr dsf was inserted from the left common femoral artery; however, additional vessel rupture was reportedly attributed to the 16fr dsf sheath. The physician opted to convert to an open procedure, and the vasculature was surgically repaired using y-graft replacement. The patient tolerated the procedure.
 
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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
damon jackson
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key15332210
MDR Text Key299037968
Report Number3007284313-2022-02094
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630028
UDI-Public00733132630028
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 Other
Reporter Occupation
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF1633
Device Catalogue NumberDSF1633
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/09/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2022 Patient Sequence Number: 1
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