A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The device was returned for evaluation.A visual inspection was performed, and fiber disturbance was noted.An in-house inflation device was used to inflate the balloon.Water was noted exiting the balloon.The balloon fibers were stripped and a hole from the user puncturing the balloon were noted.Therefore, the investigation is confirmed for the fiber disturbance, as disturbed fibers were noted on the balloon.The investigation for the reported deflation issue is confirmed, as the balloon was ruptured to be deflated.The investigation for the retraction issue and the investigation for the deflation issue are inconclusive, as the balloon was unable to be tested due to the condition of the device.However, the definitive root cause for the deflation issue, retraction issue, and fiber disturbance could not be determined based upon available information.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model cq75124 pta balloon dilatation catheter allegedly experienced a deflation issue, frayed material, and retraction problems.One patient was involved and there was no reported patient injury.This information was received from one source.The patient was a (b)(6) year-old male who weighed (b)(6) kilograms.
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