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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 DSF2433
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problems Aneurysm (1708); Pseudoaneurysm (2605)
Event Date 06/10/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, the patient underwent treatment of unknown pathology of the descending thoracic aortic (zone 0) with a conformable gore® tag® thoracic endoprosthesis and gore® tag® thoracic branch endoprostheses. On (b)(6) 2019, the pre-implant imaging revealed that the aneurysm / lesion diameter was 56. 8mm. A gore® dryseal flex introducer sheath was used for access at the left femoral artery. On (b)(6) 2019, a ct was performed and showed that the maximum aortic diameter was 56mm. Also, on (b)(6) 2019, a left femoral artery pseudoaneurysm was determined. It was reported that the event was related to the endovascular procedure. The event was resolved without sequelae. The drug therapy was admitted. The event was resolved on (b)(6) 2019. Reportedly, from (b)(6) 2019 till (b)(6) 2021, the maximum aortic diameter increased in size from 61mm to 64mm.
 
Manufacturer Narrative
A review of the manufacturing records for the device is going to be conducted. The investigation is in process. Further information will be provided. The sheath was discarded at the facility and is not available for analysis. W. L. Gore & associates, inc. (gore) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Blank fields present on this report include required fields and fields determined to be not applicable. Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable. This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report. In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint. These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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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 Key15024764
MDR Text Key295955047
Report Number3007284313-2022-02034
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630950
UDI-Public00733132630950
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/19/2021
Device Model NumberDSF2433
Device Catalogue NumberDSF2433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2018
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: 07/15/2022 Patient Sequence Number: 1
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