We have received the complaint device for evaluation and we have confirmed the reported incident.We observed the balloon in this catheter had a circumferential rupture and was missing about 3 mm of the balloon piece at its middle region.The catheter shaft was measured to be within specification.Liquid exited properly from the skive hole when we injected liquid through the catheter hub.Surgeon had tested the balloon functionality before use and found it be operational.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.Our quality control inspector had also performed pull test on a sample of the catheters from this lot number during in-process inspection.All of these units passed the qc requirements and performed as intended when tested to their validated force.Based on our observation of the returned device, it is possible that some anatomical ( calcification or stenosis in the lesion area ) or procedural factors ( use of excessive force to remove the thrombus, overinflation or over-pressurization of balloon ) may have contributed to the balloon rupture.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque or overinflated balloon.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.There was no injury to the patient as the result of this incident.Surgeon completed the procedure using a 3f single lumen catheter.
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During thrombectomy of a popliteal artery using a lemaitre 4f single lumen embolectomy catheter, surgeon inserted the catheter shaft into the patient's artery.When the balloon was inflated at its target location, it immediately ruptured.There was no injury to the patient as the result of this incident.Surgeon completed the procedure using a 3f single lumen catheter.
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