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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 DSF1833
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Occlusion (1984); Vascular Dissection (3160)
Event Date 08/12/2020
Event Type  Injury  
Manufacturer Narrative
It is unknown which device caused this adverse event so all devices are being included on this report. Additional devices include: catalog number #dsf1833/ serial #(b)(4)/ udi #(b)(4). Patient weight: asked but unavailable other relevant history, including preexisting medical conditions: asked but unavailable. Concomitant medical products and therapy dates: asked but unavailable.
 
Event Description
On (b)(6) 2020 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® dryseal flex introducer sheaths as accessories in the procedure. Prior to inserting the introducer sheaths, the patient's right internal iliac artery was coil embolized. It was reported that a gore® dryseal flex introducer sheath was inserted on the patient's left side. After stent graft deployment, dissection of the patient's left iliac artery was observed. The physician stated that, during coil embolization of the patient's right internal iliac artery, the guidewire entered the patient's left internal iliac artery many times. The physician therefore suspected that it was possible that an adverse event may have occurred at that time. The physician also reported that there was a possibility that the bifurcation of the patient's left internal and external iliac arteries had calcification, and dissection occurred when the introducer sheath was inserted. It was reported that the middle portion of the patient's left internal iliac artery was occluded due to the dissection. Distal blood flow via collateral flow was confirmed. Stent graft deployment was completed with no reported issues. The dissection of the patient's left iliac artery will be monitored. 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 Key10512049
MDR Text Key206301245
Report Number3007284313-2020-01059
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 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF1833
Device Catalogue NumberDSF1833
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 Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2020
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: 09/09/2020 Patient Sequence Number: 1
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