This manufacturer's preliminary investigation was conducted prior to receiving the used device for investigation and is based on the incident description by the user, the angiographic images that were sent, the examination of the lot history record of the involved device, and the manufacturer's assumptions.The sequre microcatheter was used for the injection of embozene microspheres and then contour pva particles, during a uterine fibroid embolization procedure.During the procedure, a small arterial vasospasm was realized.Verapamil was injected to counter the spasm and no clinical sequel regarding the vasospasm was mentioned.The physician noticed the clogging following the flushing of the microcatheter with saline.It is assumed that the clogging inside the microcatheter was a result of the injection of the pva particles since they were used after the embozene microspheres and pva particles are known to have a higher clogging rate than other embolization materials.From the angiographic images, it seems that the microcatheter was already kinked/distorted at this point.It is possible that the kink/distortion resulted from flushing of the catheter with saline which caused an internal high pressure and possible distortion of the sequre side slits.Thereafter, when the physician tried to open the blockage by inserting the guidewire he felt the resistance was relieved but then noticed on the angiographic imaging that the distal end (seems to be from the kinked/distorted area) of the sequre 2.8fr-150cm microcatheter had broken off.Importantly, the physician managed to retrieve the broken tip using another microcatheter as a guiding catheter for a snare.There were no remaining foreign objects in the patient and the procedure was completed successfully with no known clinical sequel to the patient.The device lot history record (lhr) from production was reviewed with no unusual findings that may have led to any malfunction of the device.Blockages of microcatheters during embolization are a known and well-defined risk and pva particles are known to have a higher clogging rate than other embolization materials.This is most likely due to particulate aggregation, making the effective size of the pva particles larger than their actual size.Importantly, the adverse event that occurred relates to the events following the clogging.Once blockages occur, it is recommended to remove the microcatheter in full from the patient.Therefore, the sequre ifu, includes warnings not to use excessive force when advancing a guidewire through a kinked/blocked microcatheter and to replace the device with a new one if resistance is felt during injection, in order to avoid potential vessel damage/injury.Conclusion: the manufacturer's preliminary investigation finds that the detachment of the distal region of the sequre catheter was a result of additional events which occurred during the procedure after the clogging of the device.Initially, the catheter clogged during embolization with pva particles.It should be noted that clogging of microcatheters is a known event and should it occur, removal of a clogged catheter without further manipulation would result in procedural delay.Since further manipulation of the kinked/distorted catheter was performed in order to open the blockage with guidewire, mechanical damage to the microcatheter occurred including detachment of the distal end.Finally, the procedure was completed, and no immediate complications were noticed, and no untoward clinical findings were reported by the user.
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