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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 DSF1233
Device Problem Obstruction of Flow (2423)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 02/07/2022
Event Type  Injury  
Manufacturer Narrative
Engineering evaluation could not be performed as the device was discarded at the treating facility. According to the gore® dryseal flex introducer sheath instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to: embolization (micro or macro) with transient or permanent ischemia. Also according to the ifu, 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
The following information was reported to gore: on (b)(6) 2022, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses. During the treatment, a final angiography was conducted that revealed a thrombus formation where a gore® excluder® aaa endoprosthesis plc161400j was implanted in the left leg. To treat it, two metal non-gore stents, smart 14 mm x 60 mm and e-luminexx 14 mm x 60 mm, were placed into the plc161400j. The blood flow within the leg was observed to be improved. The patient tolerated the procedure. The physician stated that there was significant calcification of the iliac artery. The left external iliac artery had a very narrow section. The prolonged occlusion by the gore® dryseal flex introducer sheath might have caused the thrombus formation. Reportedly it was unknown whether the plc161400j was stenotic or completely occluded.
 
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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
breanna cox
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13562657
MDR Text Key288205235
Report Number3007284313-2022-01782
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132629961
UDI-Public00733132629961
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,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF1233
Device Catalogue NumberDSF1233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2021
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: 02/18/2022 Patient Sequence Number: 1
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