It was reported that the patient presented for implant of the left ventricular lead.Once the lead was placed in the target vein, the guidewire was deployed.The guidewire became stuck inside the lead and became impossible to remove, despite several attempts by the physician to force the removal.The procedure was completed with a replacement lead.On (b)(6) 2022, the patient was admitted to the emergency room with fever, dyspnea, hypotension, and pleuritic pain.Pericardial effusion was diagnosed, and the patient developed cardiac tamponade.The patient underwent pericardiocentesis and a contrast computer tomography scan was performed.The physician stated that efforts to remove the guidewire provoked a small tear into the vein.The patient was recovering in stable condition.
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The reported events were cardiac perforation and failure to remove guidewire.As received, a complete lead was returned in one piece.The reported event of guidewire could not be removed was confirmed.Visual inspection of the lead found that the inner coil was bunched at the connector region which was consistent with procedural damage.Blood was noted in this location.X-ray examination found a piece guidewire was stuck inside the middle portion of the lead, also consistent with procedural damage.The cause guidewire removal failure was isolated to the bunched inner coil and the presence of blood.Electrical testing did not find any indication of conductor fractures or internal shorts.The full measured s-curve hump height was within specification.
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