It was reported that during a recanalization procedure, the device allegedly had no more flow after treating the affected thrombus.It was further reported that the guidewire has not been able to move forward as well and therefore flushing wasn't possible anymore.Reportedly, the catheter was pulled out but it allegedly got stuck in the sheath.There was no reported patient injury.
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.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 catheter was physically investigated.The guidewire could be inserted but only up to the metal gear wheel.With the guidewire inserted to this point, aspiration was tested with water and nominal aspiration level was achieved.Therefore, a mechanical jam can be confirmed.A clear root cause could not be identified but a blockage of the catheter 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: 08/2024).H11: section a through f ¿ the information provide by bd represents all 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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It was reported that during a recanalization procedure, the device allegedly had no more flow after treating the affected thrombus.It was further reported that the guidewire has not been able to move forward as well and therefore flushing wasn't possible anymore.Reportedly, the catheter was pulled out but it allegedly got stuck in the sheath.There was no reported patient injury.
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