(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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After using the first amplatzer torqvue 45x45 delivery sheath (tv45x45), the user required a second tv45x45, as with the first tv45x45 it was impossible to pass the septum due to a kinked guidewire from another manufacturer.During the use of the second tv45x45, there was bleeding in the groin area and the case was aborted.It was reported the bleeding was caused by too much pressure advancing the sheath.Surgery was performed to stop the bleeding.The patient died 4 days post procedure due to a heart attack.Per report, there were no allegations against the sheath and the patient's death was not due to the amplatzer devices.
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