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 035 pta dilatation catheter was received for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers/y-body.No bends were noted to the catheter.The distal tip of the balloon was noted to be prolapsed.The returned unknown sheath was noted to be buckled at the distal tip and bends were noted throughout.During functional testing, the sample guidewire lumen was flushed.The patency of the guidewire lumen was tested using an in-house guidewire and was able to be inserted without issues.An in-house syringe was used flush the in-house introducer sheath without any issues.The balloon was unable to be fully inserted.No other functional testing was performed.Therefore, the investigation is confirmed for the reported difficult to remove as the distal tip of the balloon was noted to be prolapsed and the unknown sheath was buckled at its distal tip during visual evaluation of returned sample.A definitive root cause for the alleged failure to remove 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: 05/2023), g3, h6 (method).H11: h6 (result, conclusion).H11:section a through f - the information provided by bd represents all of 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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