Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and the balloon was noted to be prolapsed over the distal tip.The outer catheter shaft was noted to be stretched proximally to the balloon glue joint.No other anomalies were noted to the device.As the user reported the balloon being punctured to deflate, no inflation attempt was made.The balloon fibers were stripped and the glue bullet was noted to be pulled away from the outer catheter shaft, no longer being seated in the correct position.No anomalies were noted to the device, inflation/deflation port.Therefore, the investigation is confirmed for the reported retraction issue, as stretching was noted to the device and the balloon was noted to be prolapsed over the distal tip.The investigation is inconclusive for the reported deflation issue, as no blockage of the inflation/deflation port was noted and no functional testing could be performed due to the condition of the device.Per the reported event details, the device was unable to be deflated.Therefore, the reported deflation issue may have led to the retraction issue.However, the definitive root cause for the reported deflation issue and retraction issue could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event. 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.Additional mfr narrative: premarket identification.Device evaluated by mfr, adverse event problem, (results, conclusion).
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