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

Model Number	DSF2633
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular procedure to treat a pseudoaneurysm in the zone two using gore® tag® thoracic branch endoprostheses.A gore® dryseal sheath was used for access.Reportedly, the procedure was done according to the instructions for use (ifu).Percutaneous the right sided access was gained, sheaths up sized to dsf2633, and hemostasis was achieved as per normal operating procedures.The patient was successfully treated with a tac084015c and a tsb081506c without any complications.It was reported, that at the end of the case, during removal of the sheath and vessel closure, resistance was felt on withdrawal.Under fluoroscopy, it was noticed there was tortuosity and a kink in the external iliac artery.The sheath was pulled back, and a blush was noticed.A rupture was indicating.A gore® viabahn® endoprosthesis was deployed and excluded the rupture within 4-5 minutes.The procedure was successfully completed.In discussion with the physician, there was only noticed minimal blood loss (less than a liter) and extended or time.The mds stated there was no site complications or hematoma at the groin.No other complications.The patient awake and was eating after surgery.Set for hospital discharge on (b)(6) 2022.According to the physician, tortuosity was a cause of rupture.The vessel measurements were according to the ifu, about 8.5mm.
Additional Manufacturer Narrative
A review of the manufacturing records for the devices are going to be conducted.The investigation is in process.Further information will be provided.As it was unknown what sheath caused the issue, both devices were investigated.Also was used: dsf2633/23999765, udi# (b)(4).The sheaths were discarded at the facility and are not available for analysis.Code 4581- was used to explain that the patient had an extra procedural time.
Additional Manufacturer Narrative
H.6.Code 213: a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.It was unknown what the exact sheath was related with the event, therefore both sheaths were investigated.Also was investigated dsf2633/23999765 udi# (b)(4).The sheaths were discarded at the facility and are not available for analysis.Code 4581- was used to explain that the patient had an extra procedural time.According to the physician, tortuosity was a cause of rupture.The vessel measurements provided were about 8.5mm.According to the gore® dryseal flex introducer sheath sizing, the dsf2633 minimum sheath id is 8.7mm and the nominal sheath od is 9.5mm.According to the gore® dryseal flex introducer sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.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 blood loss, bleeding, vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13673797
• Report Number: 3007284313-2022-01809
• Device Sequence Number: 4659507
• Product Code: DYB
• UDI-Device Identifier: 00733132630103
• UDI-Public: 00733132630103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2024
• Device Model Number: DSF2633
• Device Catalogue Number: DSF2633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• 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; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 70 KG