Catalog Number UNK ROTAREX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 06/08/2023 |
Event Type
Injury
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Event Description
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It was reported in an article in the journal of ¿invasive cardiology¿ titled ¿dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound", that after three runs of device to the sixty-nine percent occluded right distal superficial femoral artery, the patient allegedly had type a dissection present at baseline of vessel wall.It was further reported that the patient underwent additional medical intervention for drug coated balloon catheter treatment.Reportedly, the patient was recovered with ten percent residual narrowing.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: as the lot number for the device was not provided, a review of the device history records could not 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: nicolas w.Shammas, james t.Torey, and w.John shammas (2018).Dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound.Journal of invasive cardiology, 30(4): 145-146.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 not returned.
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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: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the physical sample was not received for evaluation and a physical investigation was not possible.The user report contains information regarding the adverse event without identified device or use problem.Therefore, the investigation is confirmed for the reported failure.A clear root cause could not be identified but a blockage of the catheter represents a known inherent risk.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: nicolas w.Shammas, james t.Torey, and w.John shammas (2018).Dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound.Journal of invasive cardiology, 30(4): 145-146.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 not returned.
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Event Description
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It was reported in an article in the journal of ¿invasive cardiology¿ titled ¿dissections in peripheral vascular interventions: a proposed classification using intravascular ultrasound", that after three runs of device to the sixty-nine percent occluded right distal superficial femoral artery, the patient allegedly experienced type a dissection present at baseline of vessel wall.It was further reported that the patient underwent additional medical intervention for drug coated balloon catheter treatment.Reportedly, the patient was recovered with ten percent residual narrowing.The current status of the patient is unknown.
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Search Alerts/Recalls
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