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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY NBS PRO THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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BOLTON MEDICAL, INC. RELAY NBS PRO THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-N4-36-199-32U
Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921); Scratched Material (3020); Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
Event Type  malfunction  
Event Description
Tevar to treat taa.Landing in distal aorta.Access good.No scan to send.The doctor told me the size to bring to case.We did discuss and look over scan before case.No access issues.Doctor put in 2 per closes for access and then 9fr sheath.After he had his lunderquist up, he took out the 9fr and advanced the relay pro.The sheath lip got stuck and couldn't advance so he took out the device and put in a 18fr sheath to dilate the hole.He inspected the sheath tip and it was a little damaged but pressed his fingers to fix and it looked good.After dilation, the relay pro was placed again and no issues going through the groin.The deployment stents went well.At step 4, the resident walked the dilator over the wire to house in the sheath.Once it got to the sheath it got stuck.I told him to rotate the rod to get the tip in the sheath.It was stuck.The doc decided to take out the sheath at that time.When device came out of the body, we noticed the tip of the device had a sharp lip and it was stuck on the sheath that was very deformed.Access closure everything was fine, but the doctor did not like the tip sharp edge that it could have affected the closure.I told the doctor i will return the device and not to touch it or inspect it but while i was out of the room, they looked at it and "fixed" the tip edge.So just fyi when you inspect the device.Patient outcome: "no patient related issues.".
 
Event Description
Tevar to treat taa.Landing in distal aorta.Access good.No scan to send.The doctor told me the size to bring to case.We did discuss and look over scan before case.No access issues.Doctor put in 2 per closes for access and then 9fr sheath.After he had his lunderquist up, he took out the 9fr and advanced the relay pro.The sheath lip got stuck and couldn't advance so he took out the device and put in a 18fr sheath to dilate the hole.He inspected the sheath tip and it was a little damaged but pressed his fingers to fix and it looked good.After dilation, the relay pro was placed again and no issues going through the groin.The deployment stents went well.At step 4, the resident walked the dilator over the wire to house in the sheath.Once it got to the sheath it got stuck.I told him to rotate the rod to get the tip in the sheath.It was stuck.The doc decided to take out the sheath at that time.When device came out of the body, we noticed the tip of the device had a sharp lip and it was stuck on the sheath that was very deformed.Access closure everything was fine, but the doctor did not like the tip sharp edge that it could have affected the closure.I told the doctor i will return the device and not to touch it or inspect it but while i was out of the room, they looked at it and "fixed" the tip edge.So just fyi when you inspect the device.Patient outcome - "no patient related issues.".
 
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Brand Name
RELAY NBS PRO THORACIC STENT-GRAFT SYSTEM
Type of Device
STENT, ENDOVASCULAR GRAFT, AORTIC
Manufacturer (Section D)
BOLTON MEDICAL, INC.
799 international parkway
sunrise FL 33325
Manufacturer Contact
megan indeglia
799 international parkway
sunrise, FL 33325
9548389699
MDR Report Key16045701
MDR Text Key306988102
Report Number2247858-2022-00201
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P200045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/21/2023
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 Catalogue Number28-N4-36-199-32U
Device Lot Number2207210077
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/28/2022
Initial Date FDA Received12/23/2022
Supplement Dates Manufacturer Received11/28/2022
Supplement Dates FDA Received06/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age67 YR
Patient SexMale
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