STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER
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Model Number 90186 |
Device Problem
Fracture (1260)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 08/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that during the procedure, the physician was trying to remove the subject stent retriever but the junction between the stent and the wire broke as soon as it was pulled.Another retriever was used to retrieve the broken part, but it was unable to be removed and left inside the patient¿s anatomy.The procedure was completed, and patient had no other abnormal symptoms reported.No further information is available.
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Event Description
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It was reported that during the procedure, the physician was trying to remove the subject stent retriever but the junction between the stent and the wire broke as soon as it was pulled.Another retriever was used to retrieve the broken part, but it was unable to be removed and left inside the patient¿s anatomy.The procedure was completed, and patient had no other abnormal symptoms reported.No further information is available.
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Manufacturer Narrative
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A review of the device history record (dhr) for non-conforming issues and/or events was conducted for this batch.No non-conformances were raised.Although the scrapped devices could potentially relate to the reported event, the devices are inspected for damages/defects as per work instructions prior to release and all rejected devices are segregated and scrapped.Therefore, it does not appear that the lot manufacture had caused or contributed to the reported event.The dhr review indicated that all released products met specifications.Additional information provided by the customer indicated preparation/set-up was performed as per the directions for use, continuous flush maintained for the duration of the procedure, the patient anatomy was very tortuous, and no resistance encountered during the procedure.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned, a cause of 'undeterminable' shall be assigned to the as reported events.
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