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 has returned into two segments for evaluation.On the visual evaluation of the returned segments, the first segment contains the catheter shaft and the y-body and the segment consist of balloon part which noted stuck within the balloon protector and stylet, the stylet was removed from the distal tip of the balloon and the balloon protector was made a cut to remove the balloon, it was further noted that the proximal marker band was noted to dislodge and not returned for evaluation.No other anomalies noted.All the anomalies noted on the microscopic observation.No further testing performed due to the condition of the device.Therefore, the investigation for reported leak remains inconclusive as no functional evaluation couldn¿t be performed due condition of the device.The investigation was confirmed the identified balloon detachment as the returned device noted to be detached into two segments.The investigation was also confirmed for balloon marker band dislodge as the proximal marker band noted to be dislodge from the balloon and not returned for evaluation.A definitive root cause for the reported leak, identified balloon detachment, balloon marker band dislodge 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: 12/2023).
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