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

Model Number DSF1633

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

According to the gore® dryseal flex sheath instructions for use (ifu), adverse events that may occur and/or require intervention include, but is not limited to vascular trauma.

Event Description

When the gore excluder implant finished successfully, the doctor took out all of the catheters and wire guides; put the dilator inside the dryseal sheath and when the doctor pull out the device, we see an abnormal tissue stick to the dryseal; the doctor conclusion is that is vessel tissue and proceeds to do connection with surgery.The patient is alive without complications.

Manufacturer Narrative

H6.Code 213: a review of the manufacturing record for the device verified the lot met all pre-release specifications.The sheath was sent to gore and an engineering analysis was performed.The device evaluation found that the sheath was broken in the middle but did not find any tissue on the device.The root cause of the sheath damage (wire coming out of the device) could not be determined with the available information.The root cause of the presence of tissue on the sheath could not be determined with the available information because the event could not be confirmed.This type of occurrence will continue to be monitored.According to the gore® dryseal flex sheath instructions for use (ifu), adverse events that may occur and/or require intervention include, but is not limited to vascular trauma.Additionally, per ifu for the dsf1633 the id size is 5.3mm and the od size is 6.1mm.It was reported that the vessels size measured from 8mm to 10mm.

Event Description

On (b)(6) 2021 a patient was undergoing an endovascular procedure.A gore® dryseal flex sheath was used for access in the right femoral artery.After successful placement of devices, the delivery catheters and guidewires were removed.The sheath dilator was placed inside the sheath and the sheath was removed.When the sheath was removed, there was an abnormal presence of tissue on the sheath.It was determined that the tissue was vascular tissue.The vascular tissue removed from the patient's body was from the tip towards the middle of the introducer with spaces and plus or minus 2mm.A surgical repair was performed, and the patient tolerated the procedure.According to the information provided, the right common iliac artery was 9mm.The right external iliac artery was 9mm.The left common iliac artery was 8mm.The right external iliac artery was 10mm.It was reported that the device was prepared and used according to the gore® dryseal flex sheath instructions for use (ifu).The device was returned to gore and it had not been wiped off before returning it.The wire was validated to have come out of the input only.There was no evidence of resistance on insertion and removal, which was accompanied by massive bleeding and adherence of tissue.It is not known whether it was broken from the beginning, but it was evident that there was a part of the wire coming out of the device.Most of this wire was removed.The wire seemed to be broken upon removal from the patient.The device was not cut.It was removed from the patient with this appearance.More of the device was removed which appeared to be steel.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12542658
• MDR Text Key: 273668360
• Report Number: 3007284313-2021-01601
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

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: 01/23/2024
• Device Model Number: DSF1633
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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): Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 80 KG