The device was discarded and will not return for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.In this case, there was no reported device malfunction associated with the steerable sleeve guiding catheter (sgc).The reported patient effect of bleeding (hemorrhage) is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of hemorrhage was likely a result of post-procedural conditions as the sgc was inserted into the anatomy through an incision during the mitraclip procedure; the reported anemia (drop in hemoglobin) was likely a secondary effect of the hemorrhage.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
This report is filed against the steerable guide catheter due to access site bleeding, patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with chronic, ischemic functional mitral regurgitation (mr) grade 4+, and primary jet located a2p2.One mitraclip was implanted at the a2p2 without a device deficiency.The mr had been reduced to grade 1+.On (b)(6) 2020, low hemoglobin of 8.5 g/dl was noted and on (b)(6) 2020, oozing at the femoral access site was observed.Anti-platelet medication was held and one unit of red blood cells was provided.The event required prolonged hospitalization.On (b)(6) 2020, the event resolved without sequela.Per physician, there was no device issue.No additional information was provided regarding this issue.
|