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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 CATHETER, PERCUTANEOUS

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W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH CATHETER, PERCUTANEOUS Back to Search Results
Model Number DSF1233
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Aneurysm (1708)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4): the instructions for use (ifu) for the gore® dryseal flex introducer sheath it warns: do not attempt sheath advancement or withdrawal without guidewire and dilator in place, and locked to the hemostatic valve. Major bleeding, vessel damage, or serious injury to the patient, including death, may result. (b)(4)- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

 
Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and a left iliac artery stenosis. The patient was implanted with gore® excluder® aaa endoprostheses and s. M. A. R. T. ® vascular stent. A gore® dryseal flex introducer sheath (dsf) was used as a conduit for the insertion of the endoprostheses to the intended deployment locations. Post deployment of all endoprostheses, angiography revealed a dissection of the right external iliac artery. An additional stent was deployed in the right external iliac artery to cover the dissection. The patient tolerated the procedure. It was reported the dsf was advanced several times without the dilator when the dsf moved backward and may have contributed to the dissection.

 
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Brand NameGORE DRYSEAL FLEX INTRODUCER SHEATH
Type of DeviceCATHETER, PERCUTANEOUS
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
laura crawford
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11088111
MDR Text Key224101868
Report Number3007284313-2020-01206
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK160254
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 05/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDSF1233
Device Catalogue NumberDSF1233
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/29/2020 Patient Sequence Number: 1
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