MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD UT HEP; PROSTHESIS, VASCULAR GRAFT

Catalog Number IV722919

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/03/2015

Event Type  Injury  

Event Description

During surgery for a femoral to popliteal bypass a 6mmx40mm intergard heparin ultrathin graft was implanted.Following implantation it became clear the graft was highly porous.Pressure was applied by the surgical team and three units of blood were given to the patient.Bleeding through the graft subsided and the decision was taken to keep the graft in situ.Patient has hematoma in thigh and is satisfactory.Internal complaint (b)(4).

• Brand Name: INTERGARD UT HEP
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; la ciotat ; FR
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 0000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 5346659
• MDR Text Key: 35211375
• Report Number: 3008355164-2015-00169
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2015

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: 05/31/2018
• Device Catalogue Number: IV722919
• Device Lot Number: 15F11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• 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): Other
• Patient Age: 60 YR