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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 DSF1633
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Occlusion (1984)
Event Date 09/28/2020
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications. According to the gore® dryseal flex introducer sheath instructions for use (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. Additionally, the ifu states, adverse events that may occur and / or require intervention include, but are not limited to embolization (micro or macro) with transient or permanent ischemia.
 
Event Description
On (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic treatment using gore® excluder® aaa endoprostheses. A 18fr gore® dryseal flex introducer sheath was inserted from the right side and a 16 fr gore® dryseal flex introducer sheath was inserted from the left side. A trunk ipsilateral leg endoprosthesis was inserted from the right side. The ipsilateral leg was deployed, and then a contralateral leg endoprosthesis (plc121200j) was implanted from the distal of the ipsilateral leg to the right external iliac artery as planned. Two contralateral leg endoprosthesis (plc141000j and plc271200j) were implanted in the left limb. An aortic extender endoprosthesis was inserted from the right side and implanted proximally. The procedure was completed without reported issue. The patient tolerated the procedure. After the procedure, 4-5 hours later, no pulse of the left peripheral artery could be felt. The physician suspected the vessel occlusion. The angiography imaging revealed that the dorsalis pedis artery was occluded. The thrombectomy was performed on the same day of the initial procedure. The occlusion was resolved. The physician suggested that it was possible thrombus was scattered by the guide wire operation but the root cause was not determined (it was possible that the catheters and the sheath which were inserted from the left side were related to this event as well). It was reported that there was a thrombus in the aneurysm sac and there was no significant thrombus and the calcification in the patient peripheral artery.
 
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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
nataliya baramzina
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10693055
MDR Text Key211909157
Report Number3007284313-2020-01114
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
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF1633
Device Catalogue NumberDSF1633
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 Received09/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/04/2020
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: 10/16/2020 Patient Sequence Number: 1
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