Catalog Number 80202 |
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 04/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a recanalization procedure, when the catheter was inserted in the patient¿s body for aspiration, immediately abnormal sounds were heard, and the spring of the catheter was allegedly found to be ruptured.It was further reported that the tip of the catheter could not rotate when the device was re-activated and led to impossibility of liquid outflow.The procedure was completed by using another device.There was no reported patient injury.
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Manufacturer Narrative
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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: 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: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H11: section a through f: the information provide 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: device not returned.
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Event Description
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It was reported that during a recanalization procedure, when the catheter was inserted in the patient¿s body for aspiration, immediately abnormal sounds were heard, and the spring of the catheter was allegedly found to be ruptured.It was further reported that the tip of the catheter could not rotate when the device was re-activated and led to impossibility of liquid outflow.The procedure was completed by using another device.There was no reported patient injury.
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Manufacturer Narrative
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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: 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: 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 not returned for evaluation.A physical investigation was not possible.The user reported contains information regarding break and no aspiration.User provided video show no rotation of the catheter tip that indicates broken catheter helix.The reported catheter break can be confirmed.Therefore, the investigation is confirmed for the reported break issue.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f: the information provide 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 not returned.
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Search Alerts/Recalls
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