Model Number IPN037022 |
Device Problems
Material Separation (1562); Physical Resistance/Sticking (4012)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).
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Event Description
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Complaint found in maude database reports: "patient with a pre-operative diagnosis including severe aortic stenosis, prior liver transplant and femoral-femoral bypass was admitted to the operating room for placement of a central line (arrowg+ard blue mac two-lumen central venous access).Surgeon felt guidewire resistance and had to manipulate the wire to get it out.Upon inspection of the guidewire, doctor suspected a piece broke off inside the patient.Doctor placed a new line and clinical staff continued with the planned procedure.After the procedure was finished, clinical staff looked with ultrasound and x-ray and determined a part of the wire was retained inside the patient.Doctors scrubbed in to search for the part of the wire.The surgery was prolonged about 3 hours.The piece was found, taken out and sent to pathology.".
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Event Description
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Complaint found in maude database reports: "patient with a pre-operative diagnosis including severe aortic stenosis, prior liver transplant and femoral-femoral bypass was admitted to the operating room for placement of a central line (arrowg+ard blue mac two-lumen central venous access).Surgeon felt guidewire resistance and had to manipulate the wire to get it out.Upon inspection of the guidewire, doctor suspected a piece broke off inside the patient.Doctor placed a new line and clinical staff continued with the planned procedure.After the procedure was finished, clinical staff looked with ultrasound and x-ray and determined a part of the wire was retained inside the patient.Doctors scrubbed in to search for the part of the wire.The surgery was prolonged about 3 hours.The piece was found, taken out and sent to pathology.".
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Manufacturer Narrative
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(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).284980160.Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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