As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 04/2024).
|
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold pta dilatation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.However, the balloon was returned in a partially inflated condition for evaluation.On the functional testing, the balloon was inflated with an in-house presto inflation device up to 16 atm.The balloon was inflated and maintained pressure and shape.Further, the balloon was deflated in 21 seconds, which was within the acceptable limit as per the product performance specification.The balloon was further cut, and under microscopic observation, the glue bullet was not seated in the correct position.No other functional testing was performed.Therefore, the investigation for reported deflation issue was unconfirmed, as the balloon was inflated and deflated without any issue.The balloon took 21 seconds to deflate during the functional testing , which is within the acceptable limit as per the product performance specification.A definitive root cause for the reported deflation issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2024), g3.H11: b5, h6 (method, 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.
|