Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot meets all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the catheter was examined under microscopic magnification, and both the inner and outer catheter were torn and twisted around the core wire, distal to the rapid exchange junction.The outer catheter was torn at the rapid exchange junction.The inner guidewire lumen was torn and protruding out of the outer catheter.A complete break in the inner guidewire lumen was observed near the rapid exchange junction.The inner guidewire lumen and outer catheter were observed to be bunched near the distal end of the catheter.The guidewire was spiraled in appearance and was kinked in several locations.No other anomalies were noted along the length of the catheter.Functional/performance evaluation: the guidewire was unable to be removed from the catheter likely due vital fluid and bunching of the inner guidewire lumen.Further functional testing could not be performed due to the poor sample condition (i.E.Torn and broken).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: one electronic photo was returned and reviewed.The photo shows a crosser rx catheter.The guidewire is spiraled in appearance and is kinked throughout its length.The inner guidewire lumen appears to be torn and protruding out of the outer catheter.The distal end of the guidewire is protruding out the distal tip and appears to be bent.Based upon the photo provided, device-device incompatibility and a torn catheter can be confirmed.Conclusion: the device was returned and a photo was provided.The investigation is confirmed for device-device incompatibility, based on the condition of the returned sample (i.E.Guidewire was stuck inside catheter and catheter was bunched).The investigation is confirmed for torn material, as the catheter was torn at the rapid exchange junction.The investigation is confirmed for a broken inner guidewire lumen.The definitive root cause could not be determined based upon the available information.It is unknown if the original guidewire, patient issues, and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings and precautions: when using the crosser in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the crosser catheter tip.Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.It is not recommended to use the crosser over wires which have polymer-jacketed distal ends.Adverse events: as with most percutaneous interventions, potential adverse effects include: bleeding which may require transfusion or surgical intervention, hematoma, perforation, dissection, guidewire entrapment and/or fracture, hypertension/hypotension, infection or fever, allergic reaction, pseudoaneurysm or fistula aneurysm, acute reclosure, thrombosis, ischemic events, distal embolization, excessive contrast load resulting in renal insufficiency or failure, excessive exposure to radiation, stroke/cva, restenosis, repeat catheterization / angioplasty, peripheral artery bypass, amputation, death or other bleeding complications at access site.Interventional use: advance the guidewire and crosser catheter 14p, 14s, or 18 to the lesion site.Withdraw the guidewire approximately 1cm within the catheter so that the tip of the crosser catheter is the leading edge.Slowly advance the catheter tip through the lesion.Apply steady, constant pressure so the tip of the catheter is engaged to the lesion.Upon successful recanalization of the lesion, advance the guidewire distal to the lesion and then withdraw the crosser 14p, 14s, or 18 catheter.The information provided by bard 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 bard.
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