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 for the difficult to advance and balloon rupture could not be determined based upon the provided 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.(expiry date: 04/2023).
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It was reported that during an angioplasty procedure in superficial femoral artery (sfa), the drug coated balloon allegedly had difficulty to cross the lesion.It was further reported that upon reaching the target, the drug coated balloon allegedly ruptured upon inflation.The procedure was completed using another device.There was no reported patient injury.
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