Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC Back to Search Results
Catalog Number 28-N4-28-204-24S
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
Manufacturer Narrative
Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
"relaypro nbs came mislabeled because it was not 200mm.In length, it was not conical, but it was a 100mm prosthesis.In length with a single medial mark.We realized it was short when we see only a medial mark when deploying the prosthesis and not before.When she was partially released, they proceeded to free her completely.Then they introduced a pigtail inside and we verified that it was not a 20mm relaypro.Of length.When verifying that it was not 200 mm.We automatically knew that it was not tapered either because they are made in 150/200/250 mm.And never tapered standard 100 mm.We do not know if the proximal and distal diameter of this relaypro nbs is 100 mm.It was 28 mm.But from the measurements and attached photos, we believe that it may be a relaypro nbs 28x100x28 mm.Although because it come badly labeled we cannot ensure it." patient outcome: "they immediately proceeded to implement a gore c-tag inside the mislabeled relaypro nbs.They used a 200 mm implant."real" and in the photos you can appear the difference in length between both.Due to internal supply problems, you did not send any more backup units for this surgery and due to the bad labeling of the relaypro nbs and not having backup units, you had to solve this problem with a gore implant.The result was good and the problem was solved in the same surgery.".
 
Manufacturer Narrative
Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
"relaypro nbs came mislabeled because it was not 200mm.In length, it was not conical, but it was a 100mm prosthesis.In length with a single medial mark.We realized it was short when we see only a medial mark when deploying the prosthesis and not before.When she was partially released, they proceeded to free her completely.Then they introduced a pigtail inside and we verified that it was not a 20mm relaypro.Of length.When verifying that it was not 200 mm.We automatically knew that it was not tapered either because they are made in 150/200/250 mm.And never tapered standard 100 mm.We do not know if the proximal and distal diameter of this relaypro nbs is 100 mm.It was 28 mm.But from the measurements and attached photos, we believe that it may be a relaypro nbs 28x100x28 mm.Although because it come badly labeled we cannot ensure it." patient outcome: "they immediately proceeded to implement a gore c-tag inside the mislabeled relaypro nbs.They used a 200 mm implant."real" and in the photos you can appear the difference in length between both.Due to internal supply problems, you did not send any more backup units for this surgery and due to the bad labeling of the relaypro nbs and not having backup units, you had to solve this problem with a gore implant.The result was good and the problem was solved in the same surgery.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RELAY PRO NBS 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 Key18507538
MDR Text Key333213406
Report Number2247858-2024-00002
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P200045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/02/2024
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 Date12/20/2023
Device Catalogue Number28-N4-28-204-24S
Device Lot NumberB211209065
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/12/2023
Initial Date FDA Received01/12/2024
Supplement Dates Manufacturer Received12/12/2023
Supplement Dates FDA Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2021
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 Outcome(s) Required Intervention;
Patient SexMale
-
-