As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.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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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one conquest pta dilatation catheter was received for evaluation with an unknown sheath over the balloon and three way stop cock attached to the inflation luer.Under microscopic examination, buckling was noted to the distal end of the sheath with the balloon partially inflated.During functional evaluation, negative pressure was applied but was unsuccessful.An attempt was made to remove the balloon from the sheath, but strong resistance was felt with no success of removing the balloon.No other functional testing was performed.Also, one photo was provided and reviewed.The photo shows an unknown sheath loaded over the conquest balloon.Buckling is noted to the distal end of the sheath with the distal end of the balloon visible and partially inflated.Therefore, the investigation is confirmed for the reported deflation problem and sheath removal difficulty as the device was returned with an unknown sheath over the balloon which was partially inflated, and attempts to deflate the balloon and remove the sheath were unsuccessful.The failures are also confirmed from the review of the provided photo.A definitive root cause for the reported deflation problem and sheath removal difficulty 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: b5, g3, h6 (device) h11: h6 (method, result, conclusion) 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.H3 other text : see h10.
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