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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
Catalog Number DSF2233
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Stenosis (2263)
Event Date 03/25/2021
Event Type  Injury  
Manufacturer Narrative
According to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma.
 
Event Description
The following was reported to gore: on (b)(6), 2021, the patient underwent endovascular treatment of a descending aorta aneurysm. A gore® dryseal flex introducer sheath (dsf sheath) was used for access. The dsf sheath was inserted from left side. After a stent graft was placed, an intra-operative angiography imaging was performed, and no issue was observed, and the dsf sheath was removed. During closure of the access site using perclose proglide, the echo imaging revealed a stenosis at the proximal side of the puncture site due to intima damage. A surgical procedure took place to treat the damage. 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
greg rawlings
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11686432
MDR Text Key246649011
Report Number3007284313-2021-01395
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberDSF2233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
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