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Model Number 85900PST |
Device Problems
Entrapment of Device (1212); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacturer¿s policy.Weight: no information available.Relevant tests/history: no information available.Implant/explant date: not applicable for this device.The eagle eye platinum st catheter was not returned for evaluation, thus no returned product investigation was performed.Recall: 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 during a diagnostic peripheral procedure, resistance was encountered during insertion of the eagle eye platinum st catheter within the upper right arm extremity.When the physician attempted to pullback the catheter, more resistance was encountered.Ultimately, the catheter sheered and the distal tip separated from the catheter.The proximal portion of the catheter was removed and the 0.014¿ non-manufacturer guide wire was bent.The separated tip was removed with a snare and a full body fluoroscopy confirmed no piece was retained inside the patient.The patient was discharged as expected in good condition.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).
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Manufacturer Narrative
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Block h3: the eagle eye platinum st catheter was returned in two pieces.The catheter separated at the distal shaft approximately 185 mm from the tip (includes distal tip, distal and proximal fillets, scanner body, and a portion of the distal shaft).Under visual and microscopic inspection, the microcables and inner member were exposed with rough edges of malleable material.Additionally, the core wire was exposed with a sharp edge.There was no missing material, all portions of the catheter was accounted for.Block h6 correction: component code updated from 3123 (tip) to 4721 (rod/shaft).Based on the device evaluation, the distal shaft separated and not the distal tip.Block h6: the probable cause of the shaft separation is damage during use and 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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