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

Catalog Number	DSF1833
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2024 a gore® dryseal flex introducer sheath (dsf) was being used an accessory with non-gore devices to clear a blood clot.At some point in the procedure, significant bleeding was noticed through the one-way valve.The decision was made to replace the device with a different dsf.However, the new dsf also had significant bleeding through the one-way valve.The patient lost a significant amount of blood (approximately 4-5 units).The patient underwent a transfusion and is stable.Because the primary procedure was not conducted with gore device, the fsa was not present at this event.The fsa reported that it was indicated to him that in both cases, the valve leakage occurred after a device had been advanced through valve.However, the hospital risk management indicated that this information was unknown, and would not be provided.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
A.1.Patient identifier was requested from hospital but was not provided.H.6.Type of investigation code c21: investigation pending follow-up conversations with hospital risk management, and product history review, and engineering evaluation.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
H.6.Investigation conclusions code d15: there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.H.6.Type of investigation code b17: the hospital would not confirm whether they had retain or discarded the device.H.6.Type of investigation code b22: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.H.6.Investigation conclusions code d16 updated to d15.H.6.Investigation findings code c21 update to c20 and c0703.H.6.Type of investigation code b21 updated to b13, b17, and b22.
Additional Manufacturer Narrative
The event is this case is the same event documented in user facility medwatch #mw5155105.
Additional Manufacturer Narrative
H.6.Investigation findings code c19: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met creganna medical specifications and procedures.H.6.Type of investigation code b22 corrected to b14.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19527804
• Report Number: 3007284313-2024-03308
• Device Sequence Number: 18036043
• Product Code: DYB
• UDI-Device Identifier: 00733132630042
• UDI-Public: 00733132630042
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DSF1833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/05/2024; 09/03/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female