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 catheter was returned for evaluation.On visual evaluation, the balloon was noted to be detached from the catheter exposing the inner guide wire lumen and the detached balloon was not returned for evaluation.No other anomalies were noted.No functional testing was performed due to the condition of the device.Therefore, the investigation remains inconclusive for the reported difficult to remove and device-device incompatibility as no functional testing was performed due to the condition of the device returned for evaluation.The investigation is confirmed for the identified balloon detachment as the balloon was detached from the catheter exposing the inner guide wire lumen and the detached balloon was not returned for evaluation.A definitive root cause for the reported difficult to remove , device-device incompatibility and identified balloon detachment 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.(expiry date: 02/2024).
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