Catalog Number PT-65509 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports: device basket entangled with pt.'s existing stent.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was not delayed/interrupted.
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Event Description
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The customer reports: device basket entangled with pt.'s existing stent.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was not delayed/interrupted.
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Manufacturer Narrative
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(b)(4).The customer returned a 5fr ptd catheter attached to a syringe and lidstock for evaluation.The catheter was returned with the basket fully advanced out the sheath.The ptd catheter was visually inspected.None of the basket wires were broken, and the full tip was present.The catheter was also observed to be stretched out, all twisted up and damaged both in the middle and towards the proximal end.No defects or anomalies were observed on the ptd catheter other than a stent was observed entangled around the distal end of the basket.The damage to the catheter most likely occurred when the catheter basket was caught on the stent.Significant biological material was also observed where the stent was entangled.The tip of the basket measured.55" which is within specification of.5156-.5626" per product drawing.The overall length of the basket measured 3.1cm which is close to the nominal value of 3cm per product drawing.The ptd basket was unable to be retracted back into the sheath as expected.The ptd catheter was attached to an inventory rotator and the basket was unable to rotated as expected when the rotator was turned on.The catheter being twisted up and damaged are the likely causes of the device to not function as expected.A device history record review was performed on the ptd device and no relevant findings were identified.The ifu provided with this kit warns the user "the ptd device is not for use in stents." the customer complaint of the ptd catheter entangled with a stent was confirmed through this investigation.Visual inspection revealed the stent was caught within the basket of the catheter.However, according to the ifu provided with this kit, the ptd devices are not to be used in stents.Therefore, the root cause of this investigation is deemed use error.An in-service was requested to inform the customer not to use the ptd catheter inside stents.Teleflex will continue to monitor and trend for complaints of this nature.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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The customer reports: device basket entangled with pt.'s existing stent.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was not delayed/interrupted.
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Search Alerts/Recalls
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