Catalog Number 80237 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
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: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 05/2026).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.
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Event Description
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It was reported that during a recanalization procedure, the device allegedly stopped inside the stent and the spring of the device allegedly came off out of the catheter device.It was further reported that the spring was immediately taken out, slowly as not to pull it off in the patient and it barely hung on out of the sheath.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, the device allegedly stopped inside the stent and the spring of the device allegedly came off out of the catheter device.It was further reported that the spring was immediately taken out, slowly as not to pull it off in the patient and it barely hung on out of the sheath.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: 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 found peeking out of the catheter tip.The helix was broken at 70cm from the tip of the catheter.The tube is slightly kinked at 70cm from the tip of the catheter.No further physical damage was noted.Therefore, the investigation is confirmed for the reported helix break 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: (expiry date: 05/2026).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.
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Search Alerts/Recalls
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