During preparation for a medical procedure using a lantern delivery microcatheter (lantern), while placing the lantern over a non-penumbra guidewire, the physician experienced resistance and the guidewire was found to have perforated through the lantern; consequently, the lantern had broken in half.The damage to the lantern occurred prior to use and prior to inserting it into the patient¿s body; therefore, it was not used in the procedure.The procedure was completed using a new lantern with the same guidewire.
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Results: the lantern was fractured approximately 99.5 cm from the hub.The fractured distal segment of the lantern was ovalized approximately 147.0 and 149.0 cm from the hub and had coagulated blood inside the lumen.Conclusions: evaluation of the returned lantern revealed that the catheter was fractured.If the lantern is forcefully handled during preparation or use at an extreme angle, damage such as a guide wire perforating through the catheter and fracturing the device may occur.Further evaluation of the returned lantern revealed that the distal segment was ovalized and had coagulated blood inside the lumen.Based on the reported complaint and return condition, the ovalizations were likely incidental to the reported complaint.The root cause of the coagulated blood inside the lumen could not be determined.The complaint states that the damage to the lantern occurred prior to use and insertion into the patient¿s body and, therefore, it was not used in the procedure.The non-penumbra guide wire identified in the complaint was not returned for evaluation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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