It was reported that during a recanalization procedure for chronic total occlusion of superficial femoral artery via contralateral groin access, the catheter was allegedly became hot.It was further reported that while removing the device, the catheter was removed but the tip of the catheter didn't come out and remained in the sheath because the helix of the rotarex had allegedly fractured.Reportedly, the tip of the catheter was easily removed from the patient without any additional intervention because the broken portion of the helix had made it out of the sheath.There was no reported patient injury.
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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 helix was broken at 51 cm from the tip of the catheter.Therefore, the investigation is confirmed for the reported break 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: d4 (expiry date: 07/2024), g3, h6 (device) h11: h6 (method, result, conclusion) 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 for chronic total occlusion of superficial femoral artery via contralateral groin access, the catheter was allegedly became hot.It was further reported that while removing the device, the catheter was removed but the tip of the catheter didn't come out and remained in the sheath because the helix of the rotarex had allegedly fractured.Reportedly, the tip of the catheter was easily removed from the patient without any additional intervention because the broken portion of the helix had made it out of the sheath.There was no reported patient injury.
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