LUTONIX, INC LUTONIX 018 DRUG COATED DILATATION CATHETER; DRUG COATED BALLOON PTA CATHETER
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Model Number 9014 |
Device Problems
Inflation Problem (1310); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2024 |
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 device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.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 an angioplasty procedure, the drug-coated balloon allegedly twisted.Further it was reported that drug coated balloon allegedly had inflation issue.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.One photo was reviewed.The photo shows the partial portion of the balloon which appears to be bloody.A twist of balloon material was observed which was marked by the user.No other anomalies in the submitted photo.As the submitted photo shows the evidence of balloon twist, the investigation is confirmed for the reported balloon twist upon inflation.A definitive root cause for the reported balloon twist upon inflation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method).H11: b5, h6 (result, conclusion).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 an angioplasty procedure in the calcified superficial femoral artery via the right groin, the drug-coated balloon allegedly twisted upon inflation.There was no reported patient injury.
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Search Alerts/Recalls
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