It was reported that during a recanalization procedure, the device allegedly caught up within the vessel.It was further reported that removal attempt was performed, but device did not easily come out of the vessel, multiple wire exchanges performed and device was finally removed.Patient complained of pain.Reportedly the procedure was completed using another device.Patient current status was unknown.
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H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation and image was not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.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: 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.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.H3 other text : device not returned.
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It was reported that during a recanalization procedure, the device allegedly caught up within the vessel.It was further reported that removal attempt was performed, but device did not easily come out of the vessel, multiple wire exchanges performed and device was finally removed.Patient complained of pain.Reportedly the procedure was completed using another device.Patient current status was unknown.
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