Catalog Number 80219 |
Device Problems
Break (1069); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
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 products that are cleared in the us.The pro code and 510 k number for the rotarex products 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 will be 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 helix allegedly broke.It was further reported that the catheter was allegedly occluded.The procedure was completed using another device.There was no patient injury.
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Event Description
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It was reported that during a recanalization procedure in superior femoral artery via the common femoral artery contralateral approach, the helix allegedly broke.It was further reported that the catheter was allegedly occluded.The procedure was completed using another device.There was no 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 products that are cleared in the us.The pro code and 510 k number for the rotarex products 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 catheter was physically investigated.The tube of the catheter had a lot of minor deformation due to transport.No major kink was observed during investigation.Test guidewire went through without any resistance.During physical investigation the catheter ran smoothly and did not show any malfunction.Nominal level of aspiration was reached.No blockage or mechanical jam that was mentioned in the user report was observed during physical investigation.The catheter showed no malfunction and there is no apparent adverse event.Therefore, the investigation is unconfirmed for the reported break and mechanical jam.The definitive root cause could not be determined based upon 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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