BOLTON MEDICAL, INC. RELAY PRO THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC
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Catalog Number 28-M4-40-145-36U |
Device Problems
Difficult or Delayed Activation (2577); Mechanical Jam (2983); Ejection Problem (4009); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Event Description
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"the physician advanced the device in the usual fashion to the intended landing zone.The handle was used to advance the graft in position 1.Then in position 2 the physician began rotating the handle, but his hand was on the button.Nothing happened in regard to the secondary sheath.It did not retract, and the physician was rotating quite a bit.I had him take his hand off the handle and move back and forth but the button did not reengage.He then sort of hit the button and the button flipped up from the device.He was able to get it back on the device, but it would not engage.He then just started retracting the handle and the secondary sheath started coming back and the stent deployed." patient outcome: "no sequelae, and the patient was discharged the next day.".
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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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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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"the physician advanced the device in the usual fashion to the intended landing zone.The handle was used to advance the graft in position 1.Then in position 2 the physician began rotating the handle, but his hand was on the button.Nothing happened in regard to the secondary sheath.It did not retract, and the physician was rotating quite a bit.I had him take his hand off the handle and move back and forth but the button did not reengage.He then sort of hit the button and the button flipped up from the device.He was able to get it back on the device, but it would not engage.He then just started retracting the handle and the secondary sheath started coming back and the stent deployed." patient outcome: "no sequelae, and the patient was discharged the next day.".
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Search Alerts/Recalls
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