Model Number 5540 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The most likely cause of the reported event, based on this analysis is that the "inner" burst during high pressure injection and allowed the high pressure to exert on the strain relief, causing the strain relief to burst as well.Additional investigation is in progress.A follow-up report will be submitted.
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Event Description
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During the lv power injection, the yellow tubing at the hub of the catheter fractured.900 psi was used for the injection.Another langston catheter was used to complete the procedure without further incident.Reference mdr 2134812-2017-00074 for associated report.
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Manufacturer Narrative
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Mdr2134812-2017-000073.This device was returned and investigated -(also reference mdr-2134812-2017-00074, device did not return).Evaluation of this device confirmed the catheter strain relief tore during use.Dissection of the catheter revealed that the inner catheter had a longitudinal rupture approximately 2.5 inches distal to the strain relief, which likely occurred during high pressure injection and resulted in pressure build up in the strain relief area until the strain relief tore.The location of the longitudinal rupture is in an area of the inner catheter where no further manufacturing processes are performed.The component supplier investigated the returned unit and was unable to identify a cause for the longitudinal rupture.The component supplier provided test data for the burst pressure of the inner catheter shafts showing that their process is capable of meeting the burst pressure requirement.The supplier did not indicate any deviations on this lot or trend of similar events.
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Search Alerts/Recalls
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