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 035 pta dilatation catheter has returned for evaluation.No specific anomalies noted on the returned device.On the functional evaluation the inner guide wire lumen was flushed, an in-house guide wire inserted.Upon the insertion of the guide wire, a blue fiber kind material was existed out of the catheter.On further an in-house introducer sheath was flushed and the catheter was inserted without any issue.On the removal of the catheter a resistance was felt near the proximal end of balloon.All the anomalies noted on the microscopic observation.No further testing performed.Therefore, the investigation was unconfirmed for the reported difficult to advance and device-device incompatibility as the catheter was able to insert and advance on the in-house introducer sheath without any issue.However, the investigation was confirmed for the identified material separation as a blue fiber was noted on the advancement of in-house guide wire.The investigation was also confirmed for the identified difficult to remove as the catheter felt resistance during the removal from the introducer sheath, near the proximal end of the balloon.A definitive root cause for the reported difficult to advance and device-device incompatibility, identified material separation, identified 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.(expiry date: 03/2024).
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