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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) INTRODUCER, CATHETER

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W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) INTRODUCER, CATHETER Back to Search Results
Catalog Number DSF2233
Device Problem Material Separation (1562)
Patient Problem Aortic Dissection (2491)
Event Date 09/24/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, this patient underwent endovascular treatment for a thoracic aortic dissection and was implanted with conformable gore® tag® thoracic endoprostheses. The devices were advanced with a gore® dryseal flex sheath via the left common femoral artery (lcfa). During advancement the sheath was unable to be advanced further than the femoral artery. The sheath and undeployed device were removed from the patient and dilatation the left common femoral artery and left external iliac artery (leia) was performed using a pta balloon. The sheath was re-inserted into the lcfa but still unable to be advanced and was again removed from the patients vasculature. During removal of the sheath, it was noticed that the coil of the sheath was unraveled and fluoroscopy revealed the coiling of the sheath seemed to have become unraveled and the tip of the sheath and the radiopaque marker had become detached and remained in the patient's vasculature in the area of the lcfa, at the level of the leia. The sheath was replaced with a 20fr gore® dryseal flex sheath and the procedure was continued without further issue. Post deployment, a bare metal stent was placed within the area of the lcfa and leia to secure the detached sheath tip remained in place. Intra-operative doppler ultrasound was then performed and showed injury of the intima of the lcfa which was repaired surgically prior to conclusion of the procedure. The patient tolerated the procedure. The physician reported that difficulty advancing the sheath was expected as the access vessel was thin.
 
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Brand NameAORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
laura crawford
1500 n. 4th street
9285263030
MDR Report Key9187092
MDR Text Key169285428
Report Number3007284313-2019-00300
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 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/10/2022
Device Catalogue NumberDSF2233
Device Lot Number20988278
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2019
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: 10/14/2019 Patient Sequence Number: 1
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