BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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Catalog Number 28-N4-32-104-32U |
Device Problems
Ejection Problem (4009); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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"device was deployed to land distal to lsa.Steps 1-2 were executed with no issue.When attempting to deploy step 3 (sliding back the black clasp release into gray piece), the black piece slid back as expected then recoiled to original position.Dr.(b)(6) pulled back on it 3-5 times, with the same result of it springing back immediately to original position.Dr (b)(6) has deployed over 200 relay pros and said this was unlike any previous in terms of the black piece not feeling like it released.Dr.(b)(6) gently pulled the deployment mechanism down to see if it was released from the graft; it did in fact release, however the black piece never locked into place." patient outcome: "patient is okay.".
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Manufacturer Narrative
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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.
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Event Description
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"device was deployed to land distal to lsa.Steps 1-2 were executed with no issue.When attempting to deploy step 3 (sliding back the black clasp release into gray piece), the black piece slid back as expected then recoiled to original position.Dr brink pulled back on it 3-5 times, with the same result of it springing back immediately to original position.Dr brink has deployed over 200 relay pros and said this was unlike any previous in terms of the black piece not feeling like it released.Dr brink gently pulled the deployment mechanism down to see if it was released from the graft; it did in fact release, however the black piece never locked into place." patient outcome: "patient is okay.".
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Search Alerts/Recalls
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