H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one conquest pta dilatation catheter has evaluation.On the functional evaluation of the device, it appeared bloody, frayed fibers were noted at the distal tip of the balloon.No other specific anomalies noted.On the functional evaluation of the device, an in-house guide wire is inserted without any issue, on further the balloon was aspirated before inserting into the in-house sheath and the balloon inserted into the sheath without any issue.Then the balloon attempted to inflates but it was unsuccessful.The balloon was cut and observed under microscope and it was noted that the glue bullet had migrated inside the inner catheter lumen.No further testing was performed.Therefore, the identified inflation issue is confirmed as attempts made to inflate the balloon was unsuccessful.The investigation also confirmed for the identified frayed material as noted in the distal tip of the balloon.However, the reported deflation issue and retraction issue remains inconclusive as the balloon didn¿t inflate to perform further functional testing and problem could not be reproduced in laboratory condition due to the condition of the device.The definitive root cause for the alleged deflation, retraction issue, identified frayed material and inflation issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2023).H11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.
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