Catalog Number HNBR5.0-38-80-P-NS-MIK |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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As reported, after forming the "reverse curve", a beacon tip torcon nb advantage angiographic catheter's hub separated while retracting in the aorta.Resistance was not felt and the hub "disconnected and came off, no fracturing".Nothing was stuck the patient, and the occurrence was described as "unusual".At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
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Manufacturer Narrative
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This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Additional/corrected information: b5, d9, h6 (annex e and f).H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional information was received 17may2024.The intended access site was the femoral artery, but the device did not make it that far as the catheter hub broke off before entering the patient.The hub of the catheter broke "clean off" of the catheter body.The patient did not require any additional procedures or adverse effects due to the procedure.
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Search Alerts/Recalls
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