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.A manufacturing record evaluation was performed for the finished device 30102962l number, and no internal action was found during the review.Manufacturer¿s ref # (b)(4).
|
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment and a tip detachment issues occurred.During the procedure, the pentaray nav high-density mapping eco catheter became entangled in the patient¿s mechanical valve.There was difficulty in removing the catheter; however, it the pentaray nav high-density mapping eco catheter was freed and removed from the patient but the tip of one of the splines was missing with 2 electrodes (half of the spline detached).The damage resulted in wires exposed.No lifted or sharp rings were observed.The detached portion remained in the body and was found in the renal artery via x-ray.The patient was reported asymptomatic.A torflex baylis sheath 8.5 fr was used during the case.Based on the information available, it has been determined that there¿s no evidence to confirm that a medical/surgical intervention was performed; however, this issue represents a risk to the patient integrity and therefore it should be considered as a product malfunction, not as a serious injury.The medical device entrapment and the tip detachment issues are considered mdr reportable malfunctions.Per the pentaray nav high-density mapping eco catheter¿s instructions for use (ifu), "do not use pentaray¿ catheters in patients with prosthetic valves.A relative contraindication for cardiac catheter procedures is active systemic infection.".
|