Senseonics was made aware of an incident where the sensor broke during removal procedure.The transparent end piece of the sensor became came loose during removal, while trying to grab the sensor with the clamp.The hcp, however, was able to completely remove the sensor.
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Per case notes, the sensor was broken during removal into two pieces and the endcap was separated from the sensor.The hcp was able to remove both the pieces.The rma was authorized for the removed sensor but not received.The root cause for sensor fracture is usually excessive force applied by the removal clamps or grabbing an extremity of the sensor.In some cases, the patient's tissue at insertion sites may encapsulate the sensor, obstructing its removal.The doctor may then attempt excessive force on the clamps and risk fracturing the sensor.The hcp was able to remove all fragments of the broken sensor.No further resolution was found necessary.B4: date of this report updated to 29 january 2024.G3: date received by manufacturer updated to 04 january 2024.H3: device evaluated by manufacturer? not returned to manufacturer.H6: investigation findings updated to 3221.H6: investigation conclusions updated to 4311.
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