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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 06/15/2022
Event Type  Injury  
Manufacturer Narrative
W. L. Gore & associates, inc. (gore) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Blank fields present on this report include required fields and fields determined to be not applicable. Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable. This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report. In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint. These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
On (b)(6) 2022, this patient underwent endovascular treatment using gore® dryseal flex introducer sheath (dsf) and gore® excluder® aaa endoprosthesis for an abdominal aortic aneurysm and a right common iliac artery aneurysm. As a concomitant procedure, the right internal iliac artery was coil embolized. The 16 fr dsf was inserted from the right femoral artery, but the physician was unable to advance the dsf. The guidewire was changed and the dsf was advanced. All stent grafts were successfully deployed. When the dsf was retracted, access vessel rupture was observed from the right common iliac artery to the right external iliac artery. Additional stent grafts were deployed to extend the device to near the femoral artery. It was confirmed that the sheath insertion part of the right femoral artery was not damaged. The patient tolerated the procedure. The physician stated that it wasn¿t expected to rupture because of adequate anatomy in the lumen of the eia.
 
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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 Key15014516
MDR Text Key295879409
Report Number3007284313-2022-02032
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 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 Received07/14/2022
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 Received10/07/2022
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: 07/14/2022 Patient Sequence Number: 1
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