LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER
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Model Number 9010 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Restenosis (4576)
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Event Date 03/29/2022 |
Event Type
Injury
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Event Description
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It was reported through the results of a clinical trial that approximately one month and ten days post index procedure using a drug-coated balloon catheter, prolonged bleeding due to stenosis of the target lesion occurred and was successfully treated.The re-intervention was successful, and the outcome was recovered.The current status of the patient is unknown.
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Manufacturer Narrative
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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.Expiry date: 02/2024.Device not returned.
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Event Description
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It was reported through the results of a clinical trial that approximately one month and ten days post index procedure using a drug-coated balloon catheter, prolonged bleeding due to stenosis of the target lesion occurred and was successfully treated.The re-intervention was successful, and the outcome was recovered.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2024), g3, h6 (method).H11: section a through f - the information provided by bd represents all of 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 through the results of a clinical trial that approximately one month and ten days post index procedure using a drug-coated balloon catheter, prolonged bleeding due to stenosis of the target lesion occurred and was successfully treated.It was further reported that approximately eleven months and eight days post index procedure, restenosis of target lesion occurred and was successfully treated.The re-intervention was successful, and the outcome was recovered.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: (expiry date: 02/2024).H11: section a through f - the information provided by bd represents all of 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: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2024), g3.H11: section a through f - the information provided by bd represents all of 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 through the results of a clinical trial that one month and thirteen days post an index procedure completion using a drug-coated balloon catheter in the basilic vein via the left upper arm, the subject had an adverse event of prolonged bleeding due to stenosis in basilic vein which required an arteriovenous access circuit reintervention.Two months and twenty-seven days after index procedure, standard percutaneous transluminal balloon angioplasty and drug-coated balloon angioplasty procedures were performed to treat prolonged bleeding.Reintervention was successful, and the outcome of serious adverse event was resolved.It was further reported that seven months and eleven days after index procedure, the subject had an adverse event of recurrent prolonged bleeding due to stenosis in basilic vein which required an arteriovenous access circuit reintervention.Eight months and twelve days after index procedure, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.Reintervention was successful, and the outcome of serious adverse event was resolved.It was also reported that eleven months and eight days after index procedure, the subject had an adverse event of stenosis on target limb and appearances of new lesions in basilic vein due to decreased access blood flow which required an arteriovenous access circuit reintervention.Eleven months and eleven days after index procedure, standard percutaneous transluminal balloon angioplasty and drug-coated balloon angioplasty procedures were performed to treat decreased access blood flow.Reintervention was successful, and the outcome of serious adverse event was resolved.Furthermore, one year, two months, and twenty-two days after index procedure, the subject had an adverse event of left brachiobasilic fistula with pre-axillary venous stenosis due to prolonged bleeding which required an arteriovenous access circuit reintervention.One year, three months, and one day after index procedure, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.Reintervention was successful, and the outcome of serious adverse event was resolved.In addition, one year, three months, and twenty-one days after index procedure, the subject had an adverse event of recurrent stenosis on target limb left basilic vein due to prolonged bleeding which required an arteriovenous access circuit reintervention.One year, four months, and nineteen days after index procedure, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.Reintervention was successful, and the outcome of the serious adverse event was resolved.Evidently, two years, one month, and eighteen days after index procedure, the subject had an adverse event of recurrent stenosis located in basilic vein due to prolonged bleeding which required an arteriovenous access circuit reintervention.Two years, two months, and thirteen days after index procedure, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.Reintervention was successful, and the outcome of serious adverse event was resolved.Reportedly, there have been no documented device deficiencies or secondary stage procedures reported for this subject to date.The current status of the patient is unknown.
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