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

Model Number	DSF1065
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The following details were reported to gore: greetings: i wanted to make sure that this occurrence was reported.I just received the info: the case date was (b)(6) 2022, (b)(6), pediatric pulmonary conduit stent placement, (b)(6) female.Dry seal flex lot: 22470061.While placing a pulmonary conduit stent, there was resistance in advancing or removing the stent from the sheath.The sheath was removed and it was seen that the sheath had pulled apart distally.There were no issues and another stent was placed.
Additional Manufacturer Narrative
H6: added codes 213, 4315.The dryseal sheath was discarded by the site, however a jpeg image was provided and evaluated by gore engineering and showed the following: the jpeg was evaluated and the root cause of the separation of the sheath could not be determined with the available information.The procedure for event trending, analysis, and review generates documented, timely, and systematic trending and analysis of product event information to ensure that each design in distribution is performing in the field as expected.This type of occurrence has not yet been identified the trending process as requiring a capa.This type of occurrence will continue to be monitored by gore.
Event or Problem Description
On (b)(6) 2022, during placement of a pulmonary conduit stent the physician reported experiencing resistance when advancing and removing the stent through a 10 fr gore® dryseal flex introducer sheath.The sheath was removed from the patient and 12 fr gore® dryseal flex introducer sheath was used to deliver the stent and complete the procedure without issue.The removed sheath was examined and reported to have pulled apart distally.The patient tolerated the procedure without issue.

• 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: 14189921
• Report Number: 3007284313-2022-01874
• Device Sequence Number: 4297817
• Product Code: DYB
• UDI-Device Identifier: 00733132628261
• UDI-Public: 00733132628261
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 05/12/2022

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
• Device Expiration Date: 08/13/2022
• Device Model Number: DSF1065
• Device Catalogue Number: DSF1065
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2020
• 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: 2 YR
• Patient Sex: Female