The device was returned to ekos for evaluation.The reported fracture was confirmed.The returned microsonic device (msd) was fractured at the distal end of the first proximal transducer.The evaluation found pinch marks in the msd tubing, a dark bump in the msd tubing, and kinks between transducers.Review of the device history record indicate the product was manufactured according to specification and met all acceptance criteria prior to release.The instructions for use contain the following warning: "do not deform or kink the msd during delivery into the iddc.If the msd is kinked at any time, do not attempt to use the msd, as kinking may lead to degraded performance or fracture during use." when ekos field personnel followed up with the facility, they reported the patient was stable and finished therapy.
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A 106cm/40cm ekosonic catheter, (b)(4), was used to treat right leg deep vein thrombosis on (b)(6) 2017.The physician successfully placed the infusion catheter (iddc, part of the ekosonic catheter) in the patient and subsequently placed ultrasound core (msd, microsonic device) inside the iddc.After about 10-15 minutes the ekosonic control unit, which controls the ultrasound energy, alarmed with a device over temperature alarm.The physician removed the msd and noticed it was very short.He x-rayed the limb and noticed a section of the msd wire still in the patient.Physician removed ekos catheter and the msd section with no complications.Physician placed a new ekosonic catheter (50 cm) the patient completed therapy.Upon follow-up, the ekos representative added that the physician noticed a small kink in the msd wire when he opened the package.
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