(b)(4).The complaint device was not returned for investigation.A search of the complaint handling database was performed and no other incidents were identified from this lot for this issue.Based on an expanded investigation, however, a product issue related to leakage at the hub/luer was identified.The probable cause was identified as a lack of concentricity between the luer and the shaft which creates a narrow space between them.This results in restriction for the adhesive to flow evenly, creating a weak bond in the assembly.Corrective and preventive actions to address this issue have been implemented.The performance of these devices will continue to be monitored.
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It was reported that the procedure was to treat an eccentric, de novo lesion in the common iliac artery that was mildly tortuous and mildly calcified, with (b)(6) stenosis.A 5.0x20mm armada 35 percutaneous transluminal angioplasty (pta) catheter was prepped without issue and advanced to the lesion where inflation was attempted.The balloon was inflated for 30 seconds, however, pressure could not be raised higher than 8 atmospheres.Contrast appeared to drip from the guide wire lumen, although it could not be confirmed exactly where the leak was.There was no blood observed in the leaked contrast.The procedure was successfully completed with another new same-sized armada 35 pta catheter.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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