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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 Patient-Device Incompatibility (2682)
Patient Problem Rupture (2208)
Event Date 07/04/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, this patient underwent endovascular treatment of an arch aorta aneurysm using gore® tag® conformable thoracic stent graft with active control system, and a gore® dryseal flex introducer sheath as an accessory in the procedure. A proximal type i endoleak was observed on the intra-operative angiography, ballooning was performed but small endoleak remained. The physician elected to monitor it. Then, a rupture at right external iliac artery was observed on the confirmation angiography. For treatment, an additional stent graft was placed from the right common iliac artery down to right external iliac artery, and the right internal iliac artery was covered by the device. Reportedly, the right internal iliac artery had been occluded preoperatively, and no blood flow was observed. The patient tolerated the procedure.
 
Manufacturer Narrative
(b)(4). The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event. The investigation involved communication/interviews (either interpersonal or through technical means, e. G. Phone, e-mail) with persons close to the adverse event, e. G. Healthcare professionals (doctors, nurses etc. ), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient. The actual device involved in the adverse event was not returned for testing despite requests by manufacturer. Medical device was discarded at facility. The device either functioned as intended or a problem was not found. The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event. 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
samir kulovic
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key15154874
MDR Text Key297142642
Report Number3007284313-2022-02062
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630950
UDI-Public00733132630950
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 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2433
Device Catalogue NumberDSF2433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/22/2021
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: 08/03/2022 Patient Sequence Number: 1
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