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Patient identifier: requested, not provided age & date of birth: requested, not provided patient sex: requested, not provided weight: requested, not provided ethnicity: requested, not provided race: requested, not provided implanted date: device was not implanted explanted date: device was not explanted pma/510(k): is a product not shipped to the united states.Therefore, pma / 510 (k) has not been obtained for this product.The involved device, eliminate (hereinafter referred to as the involved device), only the catheter was returned and subjected to visual inspection.When we observed the appearance, we found that the distal marker part of the involved device was dislodged, and the guide wire lumen had the tear from the exit port toward the distal tip.The dislodged marker part was not returned.The distal marker part of the involved device was dislodged.The guide wire lumen had the tear from the exit port toward the distal tip.The distal marker part of the involved device was dislodged.The guide wire lumen had the tear.The guide wire lumen of the involved device had the tear from the exit port toward the distal tip.Observation of the distal tip and guide wire lumen.We observed the teared part of the guide wire lumen of the involved device by using the magnifier.We found that the guide wire lumen of the involved device was torn from the inside to the outside of the lumen from the exit port toward the distal tip.The distal radiopaque marker was dislodged as the resin stretched outward from the inside of the lumen.The distal radiopaque marker was dislodged as the resin stretched outward from the inside of the lumen.The resin stretched outward from the inside, and the guide wire lumen was torn.Simulation test was conducted of the dislodgement of distal marker and guidewire exit port tearing in the following steps.Step 1: set the compatible size guide wire to the eliminate and insert it into the ptca trainer with the compatible size guiding catheter.Step 2: operate the guide wire to form a loop on the combined guide wire.Step 3: in that state, perform the removal operation of eliminate.After the loop was formed on the guide wire, the guide wire was continuously pulled back against the resistance.The guide wire lumen began to tear from the exit.The guidewire lumen was torn over its total length, and finally the distal radiopaque marker of the eliminate was separate.As a result, the distal marker part of the eliminate was separated, and the same damage reproducibility as the involved device was confirmed.From the above results, it is presumed that the dislodgement of the distal marker and the tearing of the guide wire exit port that occurred in the involved device were due to the loop near the exit port of the combined guide wire and the removal operation in that state.The guide wire loops at the distal part of the guiding catheter, causing resistance.Pulling the catheter in stuck and loop state breaks the guide wire and damages the exit port.If the removal operation is continued in that state, the damage to the exit port reaches the distal tip and the marker is dislodged.As a result of reviewing the manufacturing record of the involved device's manufacturing lot "210101630", the dimensions of the inner and outer diameters, tensile strength, elongation, etc.Meet our standard values.The abnormality that leads to passage resistance of the guide wire and tearing of the exit port was not observed.When we observed the involved device, we found that the distal marker part of the involved device was dislodged, and the guide wire lumen had the tear.In addition, when we observed the teared part of the guide wire lumen of the involved device by using the magnifier, we found the guide wire lumen of the involved device was torn from the inside to the outside of the lumen from the exit port toward the distal tip.The distal radiopaque marker was dislodged as the resin stretched outward from the inside of the lumen.In the simulation test, performed the removal operation with the guide wire forming a loop, the guide wire was caught in the exit port, causing tearing and dislodgement of the distal radiopaque marker like the involved device.From these results, we estimate that the dislodgement of the distal marker part and the tearing of the guide wire lumen that occurred in the involved device may have been caused by the removal operation with the guide wire forming a loop.Terumo medical products (tmp)(importer) registration no.(b)(4) is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.(b)(4).
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