As reported, a saber 2mmx2cm 90 balloon was unable to be inflated.A slit on the balloon was confirmed.There was no reported patient injury.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There were no difficulties removing the product from the packaging, stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The product was inspected prior to use and appear to be normal.The device was prepped per the ifu and prepped normally (i.E.Maintain negative pressure).There were no kinks or other damages noted prior to inserting the product into the patient.It is unknown how the procedure completed however, the procedure was finished successfully.The product removed intact (in one piece) from the patient.The device will be returned for analysis.Additional procedural details were requested but are unknown.
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After further review of additional information received the sections have been updated accordingly.As reported, a 2x20mm 90cm saber balloon catheter (bc) was unable to be inflated.A slit on the balloon was confirmed.It is unknown how the procedure completed however, the procedure was finished successfully.There was no reported patient injury.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.There were no difficulties removing the product from the packaging, stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The product was inspected prior to use and appear to be normal.The device was prepped per the ifu and prepped normally (i.E.Maintain negative pressure).There were no kinks or other damages noted prior to inserting the product into the patient.The product removed intact (in one piece) from the patient.Additional procedural details were requested but are unknown.One non-sterile unit of saber 2mm2cm 90 was received coiled inside a plastic bag.The balloon was received deflated and appears to have been inflated.Per visual analysis, no frayed/split/torn conditions, nor other damages were found on the balloon.No other anomalies were observed in the returned unit.Leak test was performed, and a leakage was observed in the hub during the test.Microscopic analysis was performed, the saber catheter was inspected under vision system and no damages were observed on balloon, however, a cracked condition was observed on the unit¿s hub.The unit was sent to scanning electron microscopy (sem) analysis to identify the root cause of the leak on the hub.Sem results showed that the crack passed through the thickness of the hub.Transversal view of the fractured section of the hub showed a fracture pattern that presents evidence of plastic deformations along the fractured surfaces of the hub, commonly found on tensile fractured surfaces.No other anomalies were found during sem analysis.A device history record (dhr) review of lot 17526104 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon frayed/split/torn in patient¿ was not confirmed through analysis of the returned device since there were no damages noted to the balloon.However, a leakage was found on the saber balloon¿s hub due to cracked condition found.The exact cause of this reported failure as well the cracked condition could not be conclusively determined during analysis.Based on the limited information available for review, procedural/handling factors likely contributed to the cracked hub and subsequent leakage noted during analysis as evidenced by plastic deformations commonly found on tensile fractured surfaces.According to the ifu, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.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.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
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