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 014 pta dilatation catheter was received for evaluation loaded onto a unknown guidewire and with an unknown introducer sheath loaded over it.During visual evaluation, the sample was received with an unknown guide-wire extending out the distal end of the catheter.Stretching was observed to the outer catheter just proximal to the balloon weld.The balloon had a break at the proximal glue weld with the inner guide-wire lumen was intact.Bunching was observed to the guide-wire lumen.No kinks were noted to the catheter shaft and no anomalies to the luers/y-body.During functional testing, an attempt was made to remove the returned guide-wire but was unsuccessful.No further functional testing was conducted.Therefore, the investigation is confirmed for the reported difficult to remove and device-device incompatibility as the catheter was received loaded onto a unknown guidewire and bunching was observed to the guide-wire lumen.The investigation is also confirmed for the identified difficult to remove as the catheter was received with an unknown introducer sheath loaded over it.The investigation is also confirmed for the identified break as the balloon had a break at the proximal glue weld with the inner guide-wire lumen intact.A definitive root cause for the reported difficult to remove, device-device incompatibility and identified difficult to remove, break 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: d4 (expiry date: 09/2024), g3, h6 (method).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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