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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 DSF2233
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Occlusion (1984)
Event Date 11/08/2020
Event Type  Injury  
Manufacturer Narrative
Patient weight: asked but unavailable. Concomitant medical products and therapy dates: asked but unavailable.
 
Event Description
On (b)(6) 2020 the patient underwent emergency thoracic aortic endovascular repair to treat a descending thoracic aortic rupture. It was noted that heparin was not used in this case. A gore® dryseal flex introducer sheath was inserted from the patient's left side. A gore® tag® conformable thoracic stent graft with active control system was deployed and touch-up ballooning was performed to the proximal end of the device using a gore® tri-lobe balloon catheter. After the introducer sheath was removed, it was reported that angiography confirmed that the patient's left internal iliac artery was occluded. Reportedly there was no dissection of the artery. The physician reportedly considered that the non-heparin situation was a factor in the occlusion. It was reported that the patient's superior and inferior gluteal arteries had collateral blood flow. No additional treatment was performed for the occlusion. The procedure was completed, and 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
jenna lopez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10962062
MDR Text Key220193540
Report Number3007284313-2020-01187
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2233
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 Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2020
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: 12/07/2020 Patient Sequence Number: 1
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