MAUDE Adverse Event Report: WL GORE & ASSOCIATES GRAFT, VASCULAR PROPATEN STD WALL 4-7 MM X 45 CM; AV GRAFT

Model Number H470045A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Exsanguination (1841); Hypovolemia (2243)

Event Date 10/13/2018

Event Type  Death  

Event Description

Pt had a 3.75 hour hemodialysis treatment that was terminated at approx 11:00am.Per the er admission summary, the pt was at home with his spouse, who had left the room.When she returned, the pt was found unresponsive and bleeding from his av graft; 911 was called and the pt was transported to the er and admitted at 16:11 where iv fluids and 2 u prbc administered.The pt was intubated.He sustained a cpa in the er.The hospital was in the process of transferring pt to another hospital after resuscitation.During transfer to the ambulance, the pt coded and subsequently expired.Related medwatch report submitted to mfr and fda: 34-2597-2018-0001.

• Brand Name: GRAFT, VASCULAR PROPATEN STD WALL 4-7 MM X 45 CM
• Type of Device: AV GRAFT
• Manufacturer (Section D): WL GORE & ASSOCIATES; newark DE
• MDR Report Key: 8096900
• MDR Text Key: 128195659
• Report Number: 8096900
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: H470045A
• Device Catalogue Number: 3648009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2018
• Distributor Facility Aware Date: 10/13/2018
• Device Age: 3 WK
• Event Location: Home
• Date Report to Manufacturer: 11/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 113