No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record(s) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products include: non-bwi products: st.Jude medical 8 french sl0 sheath.(b)(4).(b)(6).
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It was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a lasso¿ 2515 variable circular mapping catheter and suffered a medical device entrapment requiring surgical intervention.At the beginning of the procedure, prior to ablation, the lasso catheter became entrapped deep in the left atrial appendage (laa).In an attempt to free the lasso catheter, the device was rotated, resulting in further entanglement.Sheath was advanced over the lasso catheter in an attempt to retrieve it.At this point, the lasso loop stretched and was released from the laa.Procedure continued.Upon maneuvering to the right pulmonary veins, the lasso loop became entrapped in the septum.When the physician attempted to maneuver the lasso catheter through the septum, the loop formed a knot.It was then determined that the loop was damaged and the mechanism was not functioning properly.Physician attempted to retrieve the lasso catheter via snare without success.Physician attempted to maneuver the sheath over the knotted tip without success.Subsequently, the lasso catheter was forcefully pulled from the left atrium into the right atrium via the septum.The lasso catheter was then pulled to the groin area.A tissue cut-down was performed and the lasso catheter was removed.It was noted that there were exposed wires.Procedure delay was 30-60 minutes.The reported catheter contraction issue is not a reportable malfunction, however, since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.The issues of medical device entrapment, knotted loop and broken tip are all considered reportable malfunctions.
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