Catalog Number 80202 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Noise, Audible (3273); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a recanalization procedure in the iliac bifurcation, there was allegedly a high pitch noise and then the catheter movement was stopped immediately.It was further reported that the helix of the catheter was allegedly found to be broken under the image.Furthermore, the catheter was tried to be moved out, but the catheter tip remained in the sheath.Reportedly, two wires were used to get the catheter tip out.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 that are cleared in the us.The pro code and 510 k number for the rotarex 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 return of the sample is pending.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2026).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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Manufacturer Narrative
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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.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 catheter was returned for evaluation and a physical investigation was performed for the catheter.During physical investigation only the catheter tip with broken helix was delivered, rest of the catheter was not available in the package returned for investigation.Helix tip was broken at 2 cm from the tip.Therefore, the investigation is confirmed for the reported helix break issue.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (expiration date: 06/2026).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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Event Description
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It was reported that during a recanalization procedure in the iliac bifurcation, there was allegedly a high pitch noise and then the catheter movement was stopped immediately.It was further reported that the helix of the catheter was allegedly found to be broken under the image.Furthermore, the catheter was tried to be moved out, but the catheter tip remained in the sheath.Reportedly, two wires were used to get the catheter tip out.There was no reported patient injury.
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Search Alerts/Recalls
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