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

Model Number	DSF1665
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the gore representative became aware that the tip of a gore® dryseal flex introducer sheath had broken.The gore representative was not present at the case and is seeking additional information.
Additional Manufacturer Narrative
Age at the time of event/date of birth: this information has been requested, but has not yet been provided to gore.Gender: this information has been requested, but has not yet been provided to gore.Patient weight: this information has been requested, but has not yet been provided to gore.Other relevant history, including preexisting medical conditions: this information has been requested, but has not yet been provided to gore.Concomitant medical products and therapy dates: this information has been requested, but has not yet been provided to gore.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 findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings for device evaluation: code c19 - the device was returned for evaluation and the evaluation confirmed that the sheath was broken ~ 5cm from the leading end.The root cause of the broken sheath could not be determined with the available information.H.6.Investigation findings for communication/interviews: code c21 remains unchanged.H.6.Investigation conclusions: code d16 remains unchanged h.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation findings for device evaluation: code c21 updated to code c19.
Additional Manufacturer Narrative
B.4.Event description updated.H.6.Investigation findings for communication/interviews: code c21 updated to code c20.H.6.Investigation conclusions: code d16 updated to code d15.
Event or Problem Description
On may 8, 2023, the gore representative became aware that the leading end of a gore® dryseal flex introducer sheath (dsf) had broken during an unknown procedure.The gore representative was not present at the case.No patient harms were reported, and additional case information was unavailable and will not be provided to gore.The dsf was returned for evaluation and the evaluation confirmed that the sheath was broken approximately 5cm from the leading end.The root cause of the broken sheath could not be determined with the available information.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17056961
• Report Number: 3007284313-2023-02534
• Device Sequence Number: 18286986
• Product Code: DYB
• UDI-Device Identifier: 00733132628322
• UDI-Public: 00733132628322
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2023

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: 08/19/2023
• Device Model Number: DSF1665
• Device Catalogue Number: DSF1665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 09/07/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/18/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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 Sex: Unknown