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.One photo was reviewed.The photo shows that the balloon was bloody and appeared to be allegedly twisted at the middle segment of the balloon.No other specific anomalies were noted.Therefore, based on the photo review, the reported inflation issue was unconfirmed as no evidence noted in the submitted photo and the identified twisted balloon was confirmed as the balloon was appeared to be twisted at the middle segment of the balloon.One medical image was reviewed.The image review describes that the balloon appears properly inflated except the twisted middle segment of the balloon.Based on the image review, the reported inflation issue and the identified twisted balloon was also confirmed since the middle segment of the balloon was twisted and not inflated properly.Therefore the investigation the reported inflation issue and the identified twisted balloon was confirmed from the submitted image review, as the balloon was twisted at the middle small segment and not inflated properly.A definitive root cause for the reported inflation issue and the identified twisted balloon 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: 10/2022.
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