After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6 as reported, the saber 3mm 15cm 150cm balloon catheter was noted to have a small kink approximately 15-20cm from the tip of the catheter.This was noted after the balloon was flushed with sodium chloride as per instructions, then the unknown.018 wire would not advance more than 20cm.The catheter was flushed again, and the catheter would still not advance over the guidewire.There was no reported injury to the patient.The catheter was only taken out of its packaging minutes before use.There was no obvious damage to the box.Additional information was requested; however, the information was not obtained.Previously, no product was received for analysis, instead one file with a picture related to the reported failure was attached by the customer.The file attached shows the results of an evaluation of the unit performed by an external laboratory (smlt): saber product, lot# 82221980, cat# 48003015x.As part of the picture attached it 2 units could be observed, one of them looks kinked/bent.No other anomalies of the product can be noticed by the attached pictures.Recently, a non-sterile saber 3mm x 15cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, a kink in the inner body of the unit was observed at the distal balloon area.Also, an obstruction was found on the body shaft of unit at 23.0cm from the distal tip.No other anomalies nor damages could be observed.Gw lumen flushing was intended to be performed.However, flushing could not be achieved.Then, a guidewire insertion test was intended to be performed.An appropriate.018¿ lab sample guidewire was inserted via tip and vice versa, via hub with unsuccessful results.The guidewire could not entirely pass through the guide wire lumen of the unit.The guidewire was advanced and stopped at 23.0cm from the distal tip and no longer advanced, an obstruction was felt at this point.Per microscopic analysis, the guidewire lumen of the unit was radially cut near the obstructed area and a piece of detached inner body polyethylene tucked inside the guidewire lumen could be observed.The polyethylene material was observed kind of accordioned (zigzag) inside the guidewire lumen.The polyethylene material was taken out from the gw lumen and the polyethylene material unraveled.Also, per microscopic analysis, the inner body of the unit was cut lengthwise to obtain images of possible damages along the inner body lumen with the following results: damages were observed at 16cm from the hub, at 20cm from the hub, at 42.5cm from the hub, at 88.0cm from the hub, and at 98.5cm from the hub.Also, kinks on tip section on the inner body surface and damages on the inner body at the tip section.A product history record (phr) review of lot 82221980 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft kinked/bent - during prep¿ and subsequent findings of ¿guidewire lumen obstructed¿ was confirmed via device analysis.However, the exact cause cannot be determined.During analysis, multiple kinks were noted and the material inside the guidewire lumen was noted to be polyethylene, the same material that is comprised of the guidewire lumen inner body.It is likely the accordioned piece was sheared off at some point due to the interaction of the lining with a sharp object as evidenced by analysis and the damages noted within the guidewire lumen of the balloon catheter.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is needed.According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.¿ the product analysis suggests that the event experienced by the customer may be associated to the manufacturing process.Therefore, a risk assessment has been initiated for further investigation.
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