Catalog Number 80236 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/01/2023 |
Event Type
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: 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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2025).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, the helix was allegedly broken.It was further reported that the tip was not attached to the catheter upon removal of the catheter.Reportedly, cut down on left groin and abdomen was done to remove the broken piece.The current status of the patient is unknown.
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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: 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.The user provided report contains information regarding helix break.Due to no sample received the reported malfunction of helix break can not be confirmed.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 12/2025).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, the helix was allegedly broken.It was further reported that the tip was found to be not attached to the catheter upon removal of the catheter.Furthermore, multiple attempts were made with a ensnare to remove the broken tip but were unsuccessful.Reportedly, cut down on left groin and abdomen was done to remove the broken piece.The current status of the patient is unknown.
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Search Alerts/Recalls
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