It was reported that during an angioplasty procedure of a highly calcified target lesion in the anterior tibial artery via an ipsilateral antegrade approach, the pta balloon was allegedly unable to cross the lesion.It was further reported that the shaft of the catheter allegedly bent and contrast leaked from the catheter lumen when the physician pushed and tried to make the catheter cross the lesion.Reportedly, the failure to inflate was found outside the patient.There was no reported patient injury.
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse rx pta dilatation catheter was received for evaluation.During visual evaluation, multiple kinks throughout the catheter shaft and bunching of the balloon were observed.The sample was inadvertently severed into two segments and thus functional testing couldn't be performed.Therefore, the investigation is confirmed for the reported material deformation as multiple kinks throughout the catheter shaft and bunching of the balloon were observed.However, the investigation is inconclusive for the reported inability to cross lesion and leak as functional testing could not be performed.A definitive root cause for the alleged inability to cross lesion, material deformation and leak could not be determined based upon the provided 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: (expiration date: 10/2024).H11: section a through f ¿ the information provided 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 an angioplasty procedure of a highly calcified target lesion in the anterior tibial artery via an ipsilateral antegrade approach, the pta balloon was allegedly unable to cross the lesion.It was further reported the shaft of the catheter allegedly bent and contrast leaked from the catheter lumen when the physician pushed and tried to make the catheter cross the lesion.Reportedly, the failure to inflate was found outside the patient.There was no reported patient injury.
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