No device and no medical records were provided to the manufacturer; however a photo of the sample was provided and is currently being investigated.The lot number for the device was provided.The device history records are currently under review.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
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The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was not returned, however one electronic photo was provided for review.Based on the photo review, the investigation is confirmed for peeling of the outer pebax.However, the investigation is inconclusive for the reported unraveled balloon fibers and retraction issue, as the photo review could not confirm the reported issues, and as the sample was not returned for full visual and functional evaluation of the device.The definitive root cause for the identified peeled pebax or reported fiber and retraction issues could not be determined based upon available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date-07/2020).
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