It was reported that shaft break occurred.A 15mm x 2.50mm nc quantum apex¿ balloon catheter was selected for use to dilate the lesion.However, during preparation, it was noted that the shaft was fractured.The device was not used and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
|
Corrected device lot number from 18577043 to 18571978.Corrected device manufactured date from 11/02/2015 to 10/30/2015.Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter.The balloon, tip, shaft, and hypotube were microscopically and tactile inspected.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Microscopic examination and tactile inspection revealed numerous kinks throughout the hypotube and a complete hypotube separation 71.5cm from the end of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
|