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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 DSF2433
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 04/28/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2022, this patient underwent endovascular treatment using gore® tag® conformable thoracic stent graft with active control system (ctag/ac) and gore® dryseal flex introducer sheath (dsf) for a thoracic aortic aneurysm. As concomitant procedure, total aortic arch replacement and frozen elephant trunk technique were performed. When the first ctag/ac was deployed, proximal movement was observed. No adverse event due to the movement was reported. The second ctag/ac was successfully deployed on the proximal side. Angiography after removal of the dsf revealed traumatic injury of the right external iliac artery. After dilating the occlusion balloon catheter to intercept blood flow, and two additional stent grafts were deployed from the right common iliac artery to the right external iliac artery. The patient tolerated the procedure. Reportedly, the patient's external iliac artery had a small diameter (6. 5-7 mm) and resistance was noted while the sheath was being advanced. The nominal outer diameter of the 24fr dryseal sheath is 9. 1mm.
 
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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 Key14523329
MDR Text Key292818921
Report Number3007284313-2022-01939
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630950
UDI-Public00733132630950
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
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2433
Device Catalogue NumberDSF2433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2022
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: 05/27/2022 Patient Sequence Number: 1
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