MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCUALR GRAFT, AORTIC

Catalog Number 28-M336100362390U

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2020

Event Type  malfunction  

Event Description

"attempted to flush the device through the side port w/ 50cc of saline.Was very difficult to flush and took extreme amount of effort.Had 2 different scrub tech attempt the flush.It was noticed that the saline was starting to come out the back flush/wire port of the device.It was determined that this was not normal and i was concerned that something was not right so i decided to scrap this device and have it sent back for inspection.We opened a new device and didn't have any problems w/ flushing the new device." patient outcome: "no effect on patient as device was not inserted.".

Event Description

"attempted to flush the device through the side port w/ 50cc of saline.Was very difficult to flush and took extreme amount of effort.Had 2 different scrub tech attempt the flush.It was noticed that the saline was starting to come out the back flush/wire port of the device.It was determined that this was not normal and i was concerned that something was not right so i decided to scrap this device and have it sent back for inspection.We opened a new device and didn't have any problems w/ flushing the new device." patient outcome: "no effect on patient as device was not inserted.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCUALR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise, fl
• MDR Report Key: 9915687
• MDR Text Key: 191593844
• Report Number: 2247858-2020-00016
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 28-M336100362390U
• Device Lot Number: 1912060069
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR