Device evaluated by mfr: mustang 8.0 x 60, 75cm, 20atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 16mm distal of the proximal markerband.As per mustang specification the rated burst pressure for this device is 20 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.
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Reportable based on device analysis completed on 17-jan-2023.It was reported that balloon leak occurred.The patient underwent percutaneous transluminal angioplasty.The 50% stenosed target lesion was located in the non-tortuous and non-calcified superficial femoral artery.A 8.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the first inflation, the balloon was leaking.The device was removed, and the procedure was completed with another of same device.No patient complications were reported.However, returned device analysis revealed a balloon pinhole.
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