It was reported that during a covered endovascular reconstruction of the aortic bifurcation (cerab) procedure, it was difficult to pull the pig tail catheter into the lock to extract due to the gold markers having shifted.The catheter did not tear off.There was no reported patient injury.The device was not used to treat a chronic total occlusion (cto).The device was stored and handled per the instructions for use (ifu).The device was prepped per the instruction for use (ifu).There was no difficulty advancing the device to the target lesion or crossing the target lesion.The device passed through some acute bends.All of the marker bands were retrieved from the patient and accounted for.Additional procedural details were requested but are unknown.A non-sterile unit of cath mb 5f pig 110cm 6sh diagnostic catheter was received for analysis coiled inside a plastic bag.Per visual analysis, 16 out of 20 marker bands were found moved/out of position at the distal section of the unit.The distal section of the unit was observed under the vision system and the marker band marks on the unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).However, the unit presented with an elongation on the catheter body from 24 cm to 26.5 cm from the distal tip.Elongated length measured 2.5 cm.The catheter showed 16 marker bands (from mb 5 to mb 20) moved from their original place.Marker bands 1 to 4 remained in their original positions (the position of the marker bands is numerated from the distal end to the hub).The catheter length was measured and the result was 110.5cm long.No other anomalies were found.The od and id of the distal section was measured close to the areas where the marker bands were out of position and results were found within specification.A.038¿ emerald guide wire lab sample was inserted in the catheter via the tip.Emerald guide wire was stopped at 94.7 cm from the hub due to the marker bands moved in this site.Also, the guide wire was inserted via the tip and it went through until it was stopped at 14.5 cm from the tip.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The event reported by the customer as ¿catheter (body/shaft) - withdrawal difficulty¿ could not be confirmed due to the nature of the complaint.However, the event reported by the customer as ¿marker band-offset/out of position - in-patient¿ was confirmed due to the offset marker bands on the received catheter.The cause of the event experienced by the customer could not be conclusively determined.However, procedural factors may have contributed to the reported event as evident by elongations which could be attributed to tensile forces.According to the products instructions for use, users are warned that manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Neither the device history record review nor the product analysis suggests that the event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
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