• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number DSF1633
Device Problem Difficult to Remove (1528)
Patient Problems Aneurysm (1708); Vascular Dissection (3160)
Event Date 05/31/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was returned for analysis. The investigation is in process. Further information will be reported. 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.
 
Event Description
On (b)(6) 2022, the patient was treated for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis featuring c3® delivery system and a gore® dryseal flex introducer sheath. It was reported that the devices were prepared according to the gore® instructions for use (ifu). Reportedly, when the physician withdrawn the device and the sheath, the resistance was felt. According to the physician, there was no resistance felt when the device and the sheath were introduced, the only difficulties were while the devices were withdrawal. According to the physician, the device and the sheath were removed successfully with no problems and no harm to the patient. There was nothing in the patient's anatomy caused or contributed to the event. It was reported that the sheath had been damaged by pulling back on the graft, so another sheath was used. The procedure was completed successfully with a new device and a sheath. In addition, the femoral artery was injured due to the manipulation of the device, so stitches were required to repair it. Reportedly, the vessel measurements were according to the ifu. The cause of the withdrawal difficulty is unknown. The patient tolerated the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14750434
MDR Text Key294905082
Report Number3007284313-2022-01975
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630028
UDI-Public00733132630028
Combination Product (y/n)N
Reporter Country CodeMX
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 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/20/2022 Patient Sequence Number: 1
-
-