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Model Number 86700 |
Device Problem
Material Separation (1562)
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Patient Problems
Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information for identifier, age, weight, ethnicity and race have been unsuccessful to date.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.The implant or explant dates are not applicable to this device.Device evaluation: not applicable for this device.Device was not returned for analysis.Correction/removal #: do not apply to this submission.The instructions for use (ifu) cautions: do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
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Event Description
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This case was reviewed and investigated according to the manufacture¿s policy.It was reported during a planned diagnostic peripheral procedure, the manufacturers device was advanced easily over another manufacturers.018 sv-5 wire into an aortic bypass graft.At a certain point the physician was no longer able to advance or pull the manufacturers device back over the wire.It was "stuck".The sv-5 wire, as well as the distal end of the manufacturers device, broke off and traveled distally to the patient's profunda.The physician snared the broken pieces.This adverse event is being submitted because additional intervention was required to remove the manufacture's device.
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Manufacturer Narrative
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Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block b5: additional information obtained: when reviewing the procedure log the customer realized that the 6fr manufacturers catheter device was put through a 5fr sheath which is the reason the catheter broke.The device was discarded at the customer site.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
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Event Description
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This follow-up report #1 is being submitted to correct the patient coding from the initial report, and to report additional information received.
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Search Alerts/Recalls
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