MAUDE Adverse Event Report: MAQUET GETTINGE GROUP HEMAGUARD KNITTED; MAQUET GRAFT D. 10MM L: 70CM

Model Number GTIN 00384401014225

Device Problem Leak/Splash (1354)

Patient Problems Chest Pain (1776); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Swelling (2091); Dizziness (2194); Complaint, Ill-Defined (2331); Blood Loss (2597)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Right upper chest wall hematoma due to disrupted ex-fem bypass graft anastomosis.Findings: disrupted axillary artery-graft suture line resulting in 2 liter hematoma, minimal surgical bleeding during case, but persistent diffuse bleeding due to clopidogrel.A (b)(6) woman with significant history of peripheral vascular disease, coronary disease, hypertension who had a right axillobifemoral bypass graft on (b)(6), discharged on (b)(6).Doing well at home until awoke this am with acute pain in right upper chest and associated swelling and dizziness.Presented to ed where noted to be hypotensive and concern for graft disruption.Proceeded to operating room where pt lost a good amount of blood volume but graft leak was able to be repaired and hematoma evacuated.Brought to icu given hypotension, need for resuscitation, need for resuscitation, mechanical ventilation in setting of acidosis.

• Brand Name: HEMAGUARD KNITTED
• Type of Device: MAQUET GRAFT D. 10MM L: 70CM
• Manufacturer (Section D): MAQUET GETTINGE GROUP; la ciotat cedex 13705 ; FR 13705
• MDR Report Key: 5939138
• MDR Text Key: 54464146
• Report Number: MW5064634
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: GTIN 00384401014225
• Device Catalogue Number: HGK0010-70
• Device Lot Number: 16B18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 91