Catalog Number 80219 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2023 |
Event Type
malfunction
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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.H11: section a through f ¿ the information provided by bd represents all 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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Event Description
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It was reported that during a recanalization procedure, the tip of the catheter was allegedly sheared off.It was further reported that the detached part of the catheter was allegedly stuck in the sheath.Reportedly, it was a cross-over procedure and the ilical bifurcation was elongated and kinked.The procedure was completed using same device by removing the sheath together with the catheter.There was no reported patient injury.
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Event Description
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It was reported that during a recanalization procedure, the tip of the catheter was allegedly sheared off.It was further reported that the detached part of the catheter was allegedly stuck in the sheath.Reportedly, it was a cross-over procedure and the iliac bifurcation was elongated and kinked.The procedure was completed using same device by removing the sheath together with the catheter.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: 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 sample was returned for evaluation and a physical investigation was performed for the catheter.During physical investigation, the helix was broken at 19 cm distance from the tip of the catheter.Therefore, the investigation is confirmed for the reported helix break issue.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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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Search Alerts/Recalls
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