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

Model Number	DSF2665
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, during an endovascular procedure with cook devices a buddy wire was run through a gore® dryseal flex introducer sheath (dsf).A needle was also reported to have been advanced within the sheath.Blood loss could be seen and it was reported that the needle had punctured the bladder/tube of the sheath.The sheath was removed and another dsf was used to implant two gore® viabahn® vbx balloon expandable endoprostheses.The blood loss was not significant and did not require transfusion or cause any hemodynamic impairment to the patient.Post conclusion of the gore portion of the procedure the gore representative had left the operating room and became aware later that the patient had suffered severe blood loss and a drop in blood pressure and had coded.It was reported that they transfused the patient with approximately 3 units of blood and were able to get the patient back.No further details were known as to patient status or the cause of the code at the time this event was reported.
Additional Manufacturer Narrative
Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 3007284313-2022-01786 was submitted in error, and is hereby retracted.
Event or Problem Description
On (b)(6)2022, the physician reported that the patient had been discharged and is doing well and that the cause of the blood loss after placement of the stents is still unknown.Details of how the blood loss was resolved was not provided.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13577881
• Report Number: 3007284313-2022-01786
• Device Sequence Number: 14837618
• Product Code: DYB
• UDI-Device Identifier: 00733132628421
• UDI-Public: 00733132628421
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2024
• Device Model Number: DSF2665
• Device Catalogue Number: DSF2665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 02/18/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 02/25/2022; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG