It was reported that during a recanalization procedure in the right superficial femoral artery, the guidewire was allegedly unable to cross lesion.It was further reported that tip of the guidewire was broken and detached into patient's distal aorta.Reportedly, patient's blood pressure was dropping.The guide wire was still in the patient's aorta.The current status of the patient is unknown.
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It was reported that during a recanalization procedure in the right superficial femoral artery, the guidewire was allegedly unable to cross lesion.It was further reported that tip of the guidewire was broken and detached into patient's distal aorta.Reportedly, patient's blood pressure was dropping.The guide wire was still in the patient's aorta.The current status of the patient is unknown.
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H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.A physical investigation was performed for the catheter.The guidewire, that was reported as broken, was not delivered.It was observed that the catheter was occluded and aspiration could not be achieved.A possible reason for the reported breakage of the guidewire is the observed clogging of the catheter.When the catheter is clogged, the guidewire and the helix are attached to each other and tend to rotate along together.To prevent such clogging it is recommend to make sure there is sufficient drainage flow from the catheter.Sufficient dosage of heparin, moving the catheter back and forth during the intervention as well as addition of saline help to stabilize the drainage flow.It is recommended to have a second operator to control the flow of aspirated material into the collecting bag.¿the investigation is confirmed for the reported break issue.A clear root cause could not be identified but a broken guidewire represents a known inherent risk.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 05/2024), g3.H11: h6 (method, result, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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