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

Model Number	DSF1433
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® aaa endoprostheses and gore® dryseal flex introducer sheaths (dsfs).Patient¿s pre-operative medical history included right unilateral nephrectomy.The implantation of devices was completed without any problems.After the physician removed a dsf1433 from the patient, he attempted to close the right access site using perclose proglides; however, bleeding from the right femoral artery did not stop.Vital signs did not change.The physician pressurized the site to stop bleeding and the dsf1433 was inserted again.A surgical repair was performed to close the access site.The patient tolerated the procedure.The reporting physician commented as follows: when the dsf1433 was removed, a torn was noted on the sheath.A suture of the perclose was possibly caught in the torn of the sheath edge and cut.This might have been caused because of unideal insertion angle.
Additional Manufacturer Narrative
H6: code 3233 updated to 3221.Device was not returned for evaluation, no findings were possible.H6: code 11 updated to 4315.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13063722
• Report Number: 3007284313-2021-01719
• Device Sequence Number: 20336005
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 04/13/2023
• Device Model Number: DSF1433
• Device Catalogue Number: DSF1433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/24/2022
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG