Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.A visual inspection found bunching along the outer catheter shaft and also found that the guidewire and inner lumen had been cut at the distal end of the device and that the balloon was missing.Therefore, the investigation is inconclusive for the reported balloon rupture and inconclusive for the reported entrapment based on the returned condition of the device.Per the reported event details, it is likely that the highly calcified lesion could have contributed to the reported balloon rupture and consequently the reported entrapment.However, the definitive root cause for the reported balloon rupture or the reported entrapment could not be determined based upon the available information.It is unknown whether patient and/or procedural issues contributed to the events.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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