As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway(expiry date: 02/2024).
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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 conquest pta dilatation catheter was returned for evaluation.During visual evaluation, stretching was noted to the catheter shaft.No anomalies noted to the luers, bifurcate or glue fillets.The distal tip of the sheath was buckled and a break was noted to the sheath just below the hub.Additionally, a tear was noted.The distal tip of the balloon was damaged and frayed fibers were noted at the tip of the balloon.No functional testing was performed due to the condition of the balloon.Therefore, the investigation is inconclusive for the alleged deflation problem since no functional testing was performed due to the condition of the balloon.The investigation is confirmed for the identified material deformation since stretching was noted to the catheter shaft and the distal tip of the balloon was noted to be damaged.The investigation is confirmed for the identified material frayed since frayed fibers were noted at the tip of the balloon.The investigation is confirmed for the identified difficult to remove since the introducer sheath was returned seated over the balloon.A definitive root cause for the reported deflation problem and identified material deformation, material frayed and difficult to remove 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.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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