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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 DSF1245
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 03/18/2022
Event Type  Injury  
Event Description
On (b)(6)2022, this patient underwent endovascular treatment for abdominal aortic aneurysm with bilateral iliac aneurysms using gore® excluder® aaa endoprostheses. A short time after the surgery, no pulse could be felt in the patient's left foot. Angiography showed thrombus occlusion below the left popliteal artery (anterior tibial artery, posterior tibial artery, and peroneal artery). Therefore, a thrombectomy was performed and blood flow was improved. The physician commented that the thrombus occlusion was possibly caused by intraoperative guidewire manipulation. It was reported that the causal relation with 18fr gore® dryseal sheath was not ruled out.
 
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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 Key14111941
MDR Text Key289267741
Report Number3007284313-2022-01868
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132628117
UDI-Public00733132628117
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
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF1245
Device Catalogue NumberDSF1245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/12/2021
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: 04/14/2022 Patient Sequence Number: 1
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