MAUDE Adverse Event Report: MAQUET GETINGE GROUP / INTERVASCULAR, SAS INTERGARD; VASCULAR GRAFT

Model Number IGW0028-30

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

The interior lumen of the maquet getinge group, intergard, woven, collagen coated, woven polyester vascular graft, had some type of debris in it upon opening the graft.

• Brand Name: INTERGARD
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET GETINGE GROUP / INTERVASCULAR, SAS; rochester
• MDR Report Key: 7472455
• MDR Text Key: 107069205
• Report Number: MW5076876
• Device Sequence Number: 0
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IGW0028-30
• Device Catalogue Number: IGW0028-30
• Device Lot Number: 17H31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• 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 Age: 61 YR