Catalog Number 80219 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a recanalization procedure via the crossover approach, when trying to get the catheter out of the sheath, the tip allegedly got stocked in the sheath and got turned off.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2026) h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the catheter was returned for evaluation and hence the catheter was physically investigated.During physical investigation the test guidewire passed through the catheter until the gear wheel.The catheter was flushed with water and a lot of body material was flushed out.After running in the water nominal aspiration level was achieved.Mechanical jam of the catheter was observed during investigation.The reported break and detachment was not observed.Therefore, the investigation cannot be confirmed for the reported break and detachment issues.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiry date: 07/2026), g3, h6 (device) section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during a thrombectomy and atherectomy procedure, the catheter tip allegedly turned off.It was further reported that the tip was detached from the catheter.There was no reported patient injury.
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Search Alerts/Recalls
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