Catalog Number 80202 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/22/2023 |
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 is currently being performed.The return of the sample is pending.However, a photo and a video were 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 other text : device pending return.
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Event Description
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It was reported that during a recanalization procedure in the right superficial femoral artery via the left superficial femoral artery, the catheter was allegedly unable to be removed when expected to be flushed after the first aspiration, and therefore, the catheter was removed out of the body together with the guide wire.It was further reported that after removal, the tip of the catheter was allegedly found to be worn severely.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a recanalization procedure in the right superficial femoral artery via the left superficial femoral artery, the catheter was allegedly unable to be removed when expected to be flushed after the first aspiration, and therefore, the catheter was removed out of the body together with the guide wire.It was further reported that after removal, the tip of the catheter was allegedly found to be worn severely.The procedure was completed using another device.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 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 not returned for evaluation and a physical investigation was not possible.One photo and an video were provided for review.The user report and provided image contains information regarding catheter break.After review of the provided images break of the catheter can be confirmed.Therefore, the investigation is confirmed for the reported break issue.However, the investigation is inconclusive for the reported difficult to remove issue.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.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.H10: g3, h6 (method).H11: h6 (result, conclusion).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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