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 ultraverse 014 pta dilatation catheter has returned for evaluation.On the visual evaluation a complete circumferential break at the weld joint was observed, however the balloon was still intact with the inner guide wire lumen of the catheter.The guide wire lumen was noted to stretched and kinks noted.Both the marker bands are present within the inner guide wire lumen.No evidence of balloon rupture noted on the returned device.No specific anomalies noted.No functional testing performed due to the condition of the device returned for evaluation.Therefore, for the investigation of the reported balloon rupture remains inconclusive as no functional testing performed due to the condition of the device.The investigation for the reported detachment was confirmed as a complete circumferential break at the weld joint was observed separating the balloon from the catheter from the proximal joint, however the balloon was still intact with the inner guide wire lumen of the catheter.A definitive root cause for the reported balloon rupture and detachment of balloon 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: b5, d4 (expiry date: 10/2023), g3.H11: 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.H3 other text : see h10.
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