Manufacturing review: a manufacturing review was not requested as the lot number reported was unknown.Investigation summary: one (b)(6) catheter has been returned for evaluation.Balloon had a circumferential rupture exposing the inner guide wire lumen.The distal end of the balloon was noted to be detached and not returned.Both the marker bands are present.No other specific anomalies were noted on the returned device.All the anomalies were observed under microscopic observation.No functional testing was performed due to condition of the device.Therefore, the investigation for the reported balloon rupture was confirmed as the balloon had a circumferential rupture exposing the inner guide wire lumen.The investigation was also confirmed for the balloon detachment as the distal end of the balloon and catheter was noted to be detached and not returned for evaluation.A definitive root cause for the reported balloon rupture and 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.
|