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

Model Number DSF1633

Device Problem Difficult to Remove (1528)

Patient Problems Aneurysm (1708); Vascular Dissection (3160)

Event Date 05/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned for analysis.The investigation is in process.Further information will be reported.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

On (b)(6) 2022, the patient was treated for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis featuring c3® delivery system and a gore® dryseal flex introducer sheath.It was reported that the devices were prepared according to the gore® instructions for use (ifu).Reportedly, when the physician withdrawn the device and the sheath, the resistance was felt.According to the physician, there was no resistance felt when the device and the sheath were introduced, the only difficulties were while the devices were withdrawal.According to the physician, the device and the sheath were removed successfully with no problems and no harm to the patient.There was nothing in the patient's anatomy caused or contributed to the event.It was reported that the sheath had been damaged by pulling back on the graft, so another sheath was used.The procedure was completed successfully with a new device and a sheath.In addition, the femoral artery was injured due to the manipulation of the device, so stitches were required to repair it.Reportedly, the vessel measurements were according to the ifu.The cause of the withdrawal difficulty is unknown.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Code 213: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The sheath was returned for analysis.The device evaluation found that the sheath had been compressed at various points along its length, including its leading end.The root cause of the compression of the sheath could not be determined with the available information.This type of occurrence will continue to be monitored.It was reported that the physician felt resistance during the devices withdrawal and the femoral artery was injured.There was nothing in the patient's anatomy caused or contributed to the event.According to the gore® dryseal flex introducer sheath instructions for use (ifu), do not attempt to advance or withdraw guidewire, catheter, or other device if resistance is felt.Use fluoroscopy to determine the cause.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to / breakage of the guidewire, catheter, or other device.According to the ifu, adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).

• 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 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14750434
• MDR Text Key: 294905082
• Report Number: 3007284313-2022-01975
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

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 Model Number: DSF1633
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 59 KG