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 ultraverse rx pta dilatation catheter was returned for the evaluation.Visual evaluation was performed and noted that device appeared to be clean.Device returned into two segments, one segment contains the inflation hub connected to a 3 way- valve and second segment contains balloon with remaining portion of the catheter.Functional test was not performed due to the condition of the device.Therefore, the investigation is confirmed for the identified detachment issue, as device returned into two segments.The investigation is inconclusive for the reported balloon rupture as functional test was not performed due to condition of the device.A definitive root cause for the balloon rupture and detachment 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: 02/2022),g3,h6(method) h11: h6(result, conclusion) 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.See h10.
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