MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF1633

Device Problem Positioning Failure (1158)

Patient Problem Aneurysm (1708)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, vascular trauma (i.E., dissection, rupture, perforation, tear, etc.), or serious injury to the patient may result.

Event Description

On (b)(6) 2019, the patient underwent treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported during advancement of a 18fr gore® dryseal flex introducer sheath (dsf1833) into the right femoral artery, resistance was noted and the device was not able to be advanced due to calcification.Therefore, the sheath was replaced to a 16fr gore® dryseal flex introducer sheath (dsf1633).However, the 16fr sheath reportedly was unable to be advanced into the right femoral artery.Then the 16fr sheath was then reportedly attempted to be inserted into the left femoral artery, although the left femoral artery was also calcified.The attempted advancement of the 16fr gore® dryseal flex introducer sheath (dsf1633) to the left femoral artery was reportedly not successful.Percutaneous transluminal angioplasty of the right femoral artery was performed.The 16fr sheath was able to be inserted in to the right femoral artery.At this point, significant amount of bleeding (amount unknown) from both puncture sites and hypotension were observed.It was reported a blood transfusion was performed to treat the blood loss.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.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, vascular trauma (i.E., dissection, rupture, perforation, tear, etc.), or serious injury to the patient may result.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8350451
• MDR Text Key: 136507582
• Report Number: 3007284313-2019-00045
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: DSF1633
• Device Lot Number: 18618309
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR