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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 DSF2033
Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Patient-Device Incompatibility (2682)
Patient Problem Pseudoaneurysm (2605)
Event Date 05/13/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, the patient underwent an endovascular treatment of a thoracic arch aortic pseudoaneurysm using gore® tag® conformable thoracic stent graft with active control system. When a gore® dryseal flex introducer sheath was advanced, there was resistance and it was difficult to advance it. The physician pushed the sheath by a dilator (cook). The sheath was able to be advanced to the intended position. Then, the gore® tag® conformable thoracic stent graft with active control system was implanted successfully. The left subclavian artery was coil embolized as planned. No endoleak was observed by an entire angiography. When the sheath was removed, a tissue like intima adhered to the sheath. There was no issue for the patient blood pressure. The angiography for the access vessel didn¿t reveal any issue (it was not able to be confirmed any dissection and/or rupture site). The physician said below. The patient access vessel was narrow. There was resistance when the sheath was removed, so it is possible it caused the intima was peeled away. The access angiography didn¿t reveal any issue for the access vessel properties and didn¿t confirm any dissection and/or rupture site, so the access site was closed without additional treatment. There was also no issue by a doppler echo exam.
 
Manufacturer Narrative
(b)(4).
 
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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
samir kulovic
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14652872
MDR Text Key293691298
Report Number3007284313-2022-01958
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630066
UDI-Public00733132630066
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 Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2033
Device Catalogue NumberDSF2033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/16/2022
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: 06/10/2022 Patient Sequence Number: 1
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