Model Number 5F061503CS |
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 03/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2023).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.Device pending return.
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Event Description
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It was reported that during a stent placement procedure in superficial femoral artery through femoral access, the distal tip of the catheter delivery system was allegedly detached within the superficial femoral artery.It was further reported that the distal tip was removed with a snare via the femoral access.Reportedly, after the delivery was removed a slight bent was found on the distal part of the catheter.There was no reported patient injury.
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Event Description
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It was reported that during a stent placement procedure in superficial femoral artery through femoral access, the distal tip of the catheter delivery system was allegedly detached within the superficial femoral artery.It was further reported that the distal tip was removed with a snare via the femoral access.Reportedly, after the delivery was removed a slight bent was found on the distal part of the catheter.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2025), g3.H11: d4 (medical device lot number), h6 (method).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 stent placement procedure in superficial femoral artery through femoral access, the distal tip of the catheter delivery system was allegedly detached within the superficial femoral artery.It was further reported that the distal tip was removed with a snare via the femoral access.Reportedly, after the delivery was removed a slight bent was found on the distal part of the catheter.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was returned for evaluation.The returned delivery system was found in used condition without stent, which reportedly had been deployed inside patient.Images were provided demonstrating the broken and detached segments inside the vessel.The inner catheter cardan tube was found broken at the distal end, and a segment of the cardan tube was missing; reportedly the distal end of this catheter was removed using a snare.The investigation leads to confirmed result for inner catheter cardan tube break and detachment.The bifurcation was extremely tortuous, the anatomy was tight, and the healthcare provider considered this a contributing factor.A force increase was not felt, the guidewire was running smoothly inside the system, and the lesion was pre dilated; a slight bent was found on the distal part of the catheter upon removal.Based on the information available the investigation is closed with confirmed result for inner catheter cardan tube break and detachment.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pre dilation the instructions for use states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use states: '5f (1.67 mm) or larger introducer sheath (¿); 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter guidewire'.Regarding insertion and removal difficulty of the delivery system the instructions for use states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 09/2025), g3, h2, h6 (method) h11: d4, h6 (result, conclusion) 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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