Catalog Number 80202 |
Device Problems
Break (1069); Retraction Problem (1536); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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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: 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 was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).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that during a recanalization procedure in the right superficial femoral artery, the catheter was allegedly failed to be withdrawn when flushed.It was further reported that the tip of the catheter was allegedly found to be worn upon removal.The procedure was completed using another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 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 returned for evaluation and a physical investigation was performed for the catheter.During physical investigation the helix was peeking out 1.5 cm of the tip of the catheter.The helix was found deformed 1 cm from the tip of the catheter.Tension on the tip was slightly given but not usual.The tube was cut 30 cm from the kink protection, a lot of body material was found and the helix was found without any further damages.Mechanical jam of the catheter was observed.Therefore, the investigation is unconfirmed for the reported break and retraction problem.However, the investigation is confirmed for the identified mechanical jam.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.H10: d4 (expiry date: 05/2025).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 : see h10.
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Event Description
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It was reported that during a recanalization procedure in the right superficial femoral artery, the catheter was allegedly failed to be withdrawn when flushed.It was further reported that the tip of the catheter was allegedly found to be severely worn upon removal.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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