The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a benchmark bmx96 access system (bmx96), sendit delivery device (sendit), penumbra system red72 reperfusion catheter (red72), and a penumbra system red 43 reperfusion catheter (red43).During the procedure, the bmx96 was advanced over a guidewire and into the mid to low cervical.Next, while advancing the red72 and sendit, the physician experienced resistance and noticed the bmx96 had fallen in the arch as the red72 and sendit was being advanced further up the carotid t segment.The physician then advanced the bmx96 over the red72 and sendit to the mid cervical but was still experiencing resistance advancing the red72 and sendit.Therefore, the physician removed the sendit device and switched to a red43.Next, while advancing the red43 and guidewire into the red72, the physician noticed the bmx96 would fall back into the arch.The bmx96 was advanced back over the red72, red43, and guidewire, but the physician experienced resistance within the bmx96.Subsequently, while attempting to pull back on the red72, red43, and guidewire, the physician still experienced resistance and fractured the red72, red43, and guidewire in the vessel.It was reported that the proximal end of the red72, red43, and guidewire were then removed.Afterwards, the physician opened a velocity and upon removal from the packaging, the physician kinked the velocity.Therefore, it was not used in the procedure.The physician opened a new velocity and attempted to remove the broken red72, red43, and guidewire using a snare device through the velocity and aspirating through the bmx96, but the broken catheters and guidewire could not be removed.The procedure had ended at this point.The patient was then taken into or and the broken red72, red43, and guidewire was removed via open surgery.
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Evaluation of the returned red72 confirmed a fracture and revealed stretching at the fractured location.This indicates that the red72 was stretched prior to fracture.If the red72 is retracted against resistance during use, damage such as stretching and subsequent fracture may occur.The bmx96 being in the patient¿s aortic arch during manipulation may have contributed to the resistance during the procedure.Further evaluation of the device revealed kinks and ovalization on the catheter.This damage was likely incidental to the complaint.Penumbra catheters are 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.This report is associated with mfr report number: 1.3005168196-2023-00391 h3 other text : placeholder.
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