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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 DSF1433
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/06/2022
Event Type  Injury  
Event Description
During aorta iliac mechanical thrombectomy a dryseal flexsheath device was introduced to patient's right femoral artery. During manipulation sheath broke inside patient's artery. Fda safety report id# (b)(4).
 
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Brand NameGORE DRYSEAL FLEX INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
W.L. GORE & ASSOCIATES, INC.
MDR Report Key15249604
MDR Text Key298324490
Report NumberMW5111554
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630004
UDI-Public(01)00733132630004
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDSF1433
Device Catalogue NumberDSF1433
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/17/2022 Patient Sequence Number: 1
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