As reported, upon opening the sterile package during a diagnostic aortogram, "cracks or lacerations" were found on a torcon nb advantage angiographic catheter, near the curve of the pigtail.A photo pf the device, provided by the customer, shows two holes and possible elongation of the catheter.The device did not make contact with the patient.Another catheter was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, documentation, drawing, manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one hnb5.0-38-110-p-12s-pig was returned for investigation.No visible damage was noted throughout the shaft of the catheter.However, bonded section at the distal tip was stretched, and it appeared multiple sideports had been elongated and were no longer smooth.The endhole was smooth, round and did not appear damaged.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed one nonconforming event which could contribute to this failure mode.This nonconformance was for sideport damage.While potentially related to the reported failure, it should be noted that the affected unit was scrapped and not replaced prior to order completion.There were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with t his device, which instructs the user to inspect the product after removal from the packaging to ensure no damage has occurred.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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