Device evaluated by mfr: device analysis found a complete break in the catheter of the device.The proximal section of the device consisting of catheter and hub was returned for analysis.The detached distal section consisting of the tip, blades, markerbands, balloon material, balloon bond and distal catheter was not returned for analysis.The returned section of the device was received still loaded onto the customer¿s guidewire.Blood was observed within the lumen of the device.A visual and tactile examination identified a complete break in the shaft approximately 1210mm distal to the strain relief on the outer catheter and 1230mm distal to the strain relief on the inner catheter.Severe kinking and stretching damage was also noted along the length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.The investigator could not remove the customer¿s guidewire from the device due to the severe stretching and kinking damage identified on the catheter.No issues were noted with the catheter that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported difficulties could not be determined.(b)(4).
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