Catalog Number 80202 |
Device Problems
Break (1069); Overheating of Device (1437); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a recanalization procedure, the catheter spring was allegedly broken.It was further reported that catheter was allegedly found to be hot.Reportedly, spring was pulled out with the catcher and was found to be clogged.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: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos 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 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, the catheter spring was allegedly broken.It was further reported that the catheter was allegedly found to be hot.Reportedly, spring was pulled out with the catcher and was allegedly found to be completely clogged.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 physical sample was not returned for evaluation and a physical investigation was not possible.The user provided report contains information regarding helix break.Provided images show broken helix.User reported mechanical jam and overheating due to no sample received was not confirmed.Therefore, the result of the investigation is confirmed for the reported helix break issue.However, the investigation is inconclusive for the reported mechanical jam and overheating of device issue.The definitive root cause could not be determined based upon the provided information.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 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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Search Alerts/Recalls
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