It was reported that during an angioplasty procedure, the pta balloon was allegedly twisted.Reportedly, it was difficult to remove the balloon and the catheter shaft allegedly detached during removal.The distal catheter segment was removed using guiding sheath.There was no reported patient injury.
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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 catheter in two segments has returned for evaluation.On the visual evaluation of the device, it appeared to be bloody and the device returned in two segments in which one part contains the inflation hub catheter and partial inflation lumen.The second segment contains remaining inner lumen with the distal tip inverted within the balloon.No other specifics anomalies noted.No functional performed due to the condition of the device.Therefore, the investigation as confirmed for the reported detachment of device has confirmed as the device returned in two segments.The investigation for reported difficult to remove remains inconclusive as no evidence noted to the device which returned for evaluation.The investigation remains inconclusive for the reported material twist as no evidence identified in the evaluation of returned device.Although it is likely the alleged difficult to remove led to the alleged detachment of device.A definitive root cause for the alleged material twist, detachment of device and difficult to remove 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: 03/2023), g3.H11: h6 (method, result and 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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It was reported that during an angioplasty procedure in the lesion below the knee, the pta balloon was allegedly twisted.Reportedly, it was difficult to remove the balloon and the catheter shaft allegedly detached during removal.The distal catheter segment was removed using guiding sheath.There was no reported patient injury.
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