Catalog Number 80219 |
Device Problems
Retraction Problem (1536); Mechanical Jam (2983)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)
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Event Date 12/13/2023 |
Event Type
Injury
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Event Description
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It was reported that during a recanalization procedure, the catheter allegedly got stocked inside the vessel with the motor on and was retracted together with the wire.It was further reported that the patient allegedly experienced bleeding due to vessel rupture.Reportedly, the patient underwent surgical p3-bypass procedure for treatment.The patient is stable now.
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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.However, images were provided for review.The investigation of the reported event is currently underway.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.
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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.A catheter was physically investigated.During physical investigation the test guidewire did not pass through the metal gearwheel even after flushing.After running in the water nominal aspiration level was achieved.Mechanical jam of the catheter was observed during physical investigation.Therefore, the reported retraction problem can not be confirmed and the investigation is confirmed for the identified mechanical jam issue.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.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.
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Event Description
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It was reported that during a recanalization procedure, the catheter allegedly got stocked inside the vessel with the motor on and was retracted together with the wire.It was further reported that the patient allegedly experienced bleeding due to vessel rupture.Reportedly, the patient underwent surgical p3-bypass procedure for treatment.The patient is stable now.
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Search Alerts/Recalls
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