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

Model Number DSF1433

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

Testing of actual/suspected device.A return kit was issued and sent to the reporter for return of the device.To date the device has not been received for evaluation but is expected.Communication/interviews- additional information in regard to the event of the case was requested.The provided additional information is captured in the event description.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.

Event Description

A medwatch report was received from the fda (mw5111554).As reported, during an aorta iliac mechanical thrombectomy on (b)(6) 2022, a gore® dryseal flex introducer sheath was introduced to the patient's right femoral artery.It was reported by the physician that, during manipulation and retraction on the sheath the tip of the sheath broke off inside patient's artery.As reported, several attempts were made in an effort to retrieve the proximal tip: trying to thread a wire and using a snare to remove it.However, these attempts were not successful in removing the tip of this sheath from the patient.As reported by the physician, the attempt to retrieve the sheath tip was discontinued as it was perceived to be unsafe and of no medical benefit as the "given the fact that the patient still did not have pain and ct through his aorta and knowing that his endograft would be occluded still.".Reportedly the patient was discharged home the following day.Reportedly there was no identified arterial damage or perforation.It was requested but not indicated if there was any hemodynamic impairment (e.G.Tachycardia, hypotension, ¿coding¿ or cardiopulmonary resuscitation, etc.) resulting from any bleeding.As reported, during the procedure the patient received transfusion of 2 units of blood.The device was saved and is being returned for investigation.Additional information regarding the previously implanted device that was occluded was requested.

Manufacturer Narrative

The following information was requested but was not made available by the treating facility: name, date of birth, gender, weight, medications, and comorbidities.H6.Medical device problem code, a010436: problem associated with undesired damage or breakage of those materials used in the device construction.H6.Code b13, communication/interviews- additional information in regard to the event of the case was requested.The provided additional information is captured in the event description in section b5 h6.Code c19, no device problem found: a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.H6.Code d16, cause not established: the device evaluation found that the leading tip of the sheath was missing.Exposed wire could be seen in the area of the leading tip.Most of the length of the sheath was found to be kinked.The root cause of the sheath damage and kinking could not be determined with the available information.The procedure for event trending, analysis, and review, md24024, 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 through md24024 trending process as requiring a capa.This type of occurrence will continue to be monitored through md24024.B5 describe event or problem, updated to include current summary of events and provided information d9 device available for evaluation and returned to manufacturer updated to yes.Date device returned to manufacturer indicated as 10-oct-2022 as this was the date the return was received.G2 report source was populated as health professional and user facility g3/g4 date received by manufacturer was updated to 05-nov-2022, as evaluation activities were completed in full on this date.H3 device evaluated by manufacture was updated to yes.

Event Description

A medwatch report was received from the fda (mw5111554).As reported, during an aorta iliac mechanical thrombectomy on (b)(6), 2022, a gore® dryseal flex introducer sheath was introduced to the patient's right femoral artery.It was reported by the physician that, during manipulation and retraction on the sheath the tip of the sheath broke off inside patient's artery.As reported, several attempts were made in an effort to retrieve the proximal tip: trying to thread a wire and using a snare to remove it.However, these attempts were not successful in removing the tip of this sheath from the patient.As reported by the physician, the attempt to retrieve the sheath tip was discontinued as it was perceived to be unsafe and of no medical benefit "given the fact that the patient still did not have pain and ct through his aorta and knowing that his endograft would be occluded still." reportedly, the patient was discharged home the following day.Reportedly, there was no identified arterial damage or perforation.It was requested but not indicated if there was any hemodynamic impairment (e.G.Tachycardia, hypotension, ¿coding¿ or cardiopulmonary resuscitation, etc.) resulting from any bleeding.As reported, during the procedure the patient received transfusion of 2 units of blood.It was requested but remains unknown what was inserted into the sheath or the diameters of what was inserted before the sheath broke.Additional information regarding the previously implanted device that was occluded was requested.It was requested but remains unknown if the reported occlusion was associated with a gore device.The gore® dryseal flex introducer sheath was returned to gore for evaluation.

Manufacturer Narrative

H6: medical device code a24; adverse event without identified device or use problem code added.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15513656
• MDR Text Key: 300880692
• Report Number: 3007284313-2022-02135
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: DSF1433
• Device Catalogue Number: DSF1433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/05/2022; 01/03/2023; 01/03/2023
• Supplement Dates FDA Received: 11/08/2022; 01/03/2023; 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10/H11
• Patient Outcome(s): Other