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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER

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W.L. GORE & ASSOCIATES GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Catalog Number DSF2033
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Stenosis (2263)
Event Date 04/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The review of the manufacturing paperwork verified that this lot met all pre-release specifications. The gore® dryseal flex introducer sheath instructions for use (ifu) states that adequate vessel access is required to introduce the sheath into the vasculature. Adverse events that may occur and/or require intervention include, but are not limited to: vascular trauma (i. E. , rupture). If the vessel size is smaller than the introducer sheath outer diameter (8. 3mm for a 22fr and 6. 6mm for a 20fr sheath), then vessel damage may result. (b)(4).
 
Event Description
On (b)(6) 2018, the patient underwent treatment of a thoracic aortic pseudoaneurysm with conformable gore tag® thoracic endoprosthesis using gore® dryseal flex introducer sheath. An access was made from the left groin. It was reported the physician made several attempts to advance a 22fr sheath (dsf2233/17609098), however, was not able to advance the 22fr sheath due to resistance. The physician then advanced a 20fr sheath (dsf2033/17773216), and was able to advance it with no resistance. The physician removed the 20fr sheath from the patient and made another attempt to advance the 22fr sheath again, however, was not able to advance the 22fr sheath. The physician then advanced the 20fr sheath again and implanted the endoprosthesis successfully. After the 20fr sheath was removed from the patient, an angiography showed there was a suspected dissection from the left common iliac artery to the left external iliac artery. In order to treat the dissection, two bare metal stents (epic 12mm x 60mm, 10mm x 60mm) were implanted from the left common iliac artery to the left external iliac artery. The procedure was finished without further reported issues. The physician stated that the access vessel was access vessel was partially stenosed due to thrombus and calcification and was less than 6 mm in diameter, so the access vessel trauma had been expected. The clinical specialist reported that the dissection had been caused with the 20fr sheath since the physician was only able to advance the tip (the distal end) of the 22fr sheath.
 
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Brand NameGORE® DRYSEAL FLEX INTRODUCER SHEATH
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
rachael chascsa
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7481820
MDR Text Key107189124
Report Number3007284313-2018-00143
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 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/09/2021
Device Catalogue NumberDSF2033
Device Lot Number17773216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2018
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: 05/02/2018 Patient Sequence Number: 1
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