It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and developed hypotension requiring percutaneous cardiopulmonary support system (pcps).It was also reported that a medical device entrapment occurred and required surgical intervention.During the procedure, transseptal puncture was performed with the brackenborough (bb) technique using a sound star catheter (after mitral replacement).The map of the left atrium (la) was created with a pentaray nav high-density mapping eco catheter.During mapping, the pentaray nav high-density mapping eco catheter got stuck in a prosthetic valve and was unable to be retrieved, even if the sheath was pushed and pulled closed where it was stuck.Then, the patient¿s blood pressure started to decline, and percutaneous cardiopulmonary support system (pcps) was inserted to maintain hemodynamics.The catheter shaft was needed to be cut and fixed to the spline that was stuck along the snare catheter.The catheter was successfully removed from the patient¿s body.The patient recovered blood pressure and self-pulse and was transferred to the intensive care unit (icu).The patient was reported in stable condition with the expectation to be discharged from the hospital.Physician¿s opinion regarding the cause of the adverse event is unknown.Per pentaray nav eco catheter 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.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
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On september 17, 2019, the biosense webster, inc.Product analysis lab received the device for evaluation and upon initial visual inspection, it was reported that the overall view of the spine tip section and the shaft measuring approximately 117 cm with sheath and guide wire attached to spine b.The handle was cut off and not returned.The sheath with the guide wire were attached to spine b, twisted on the proximal side of ring #6 with copper wire twisted around it.Ring #7, marker ring and ring # 8 have moved out from the polyurethane (pu) margins and are rough.The sheath and guide wire were twisted around spine b and broken lead wire was sticking out.Additional information was received on october 2, 2019 and it was noted that the patient was a female, therefore, section a3.Sex has been populated with f.It was also reported that the patient¿s outcome was improved and the physician¿s opinion on the cause of this adverse event is that it was procedure related.Investigation summary: a visual inspection was performed on the device.Several damages were observed on the spines and rings of the catheter including a part of the electrical wires were exposed.The damages observed might be related to the efforts to disengage the catheter from the prosthetic valve.Handle was separated from the device and not returned which is expected since it was reported that the catheter was cut during the procedure.There is no alleged product malfunction reported on the device during the procedure.There is evidence that catheter was manufactured in accordance with documented specification and procedures.The instructions for use (ifu) states that pentaray devices should not be used in patients with prosthetic valves.It is also stated that careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.The customer complaint has been verified.Based on available information, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.Manufacturer's reference # (b)(4).
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