VOLCANO CORPORATION EAGLE EYE PLATINUM ST RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR
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Model Number 85900PST |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacturer¿s policy.Block a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is italy.Block h3 & h6: based on the photo received of the eagle eye catheter, the tip separation was confirmed.The eagle eye catheter was not returned for evaluation, thus the cause of the tip separation could not be established.Blocks h7 & h9: do not apply to this submission.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 an alleged death or deterioration in the state of the health of any person.
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Event Description
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It was reported that an eagle eye platinum st catheter was used in a diagnostic coronary procedure in a moderately calcified mid lad.During removal, resistance was noted and the distal tip became detached within the non-philips guiding catheter.Therefore, the eagle eye catheter and guiding catheter were removed as a system.The procedure was completed with another eagle eye catheter.No patient injury reported.This product problem is being submitted due to the tip separation, potential for harm if the malfunction were to recur.
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Manufacturer Narrative
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Blocks d9 & h3: eagle eye catheter was returned for evaluation.Block h3: the eagle eye catheter was returned with the separated distal portion.Visual inspection found the scanner body had separated from the proximal fillet.At the location of separation, sharp edges of non malleable material was observed.Block h6: the probable cause of the separated distal portion is damage during removal/handling.Strain, impact, and forces associated with use can affect the integrity of the device.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 an alleged death or deterioration in the state of the health of any person.
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Search Alerts/Recalls
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