It was reported, upon opening the advance 14 lp low profile balloon catheter, an unknown gel-like substance was visualized on the balloon.The physician did not use the complaint device; therefore, it did not make contact with the patient.Another balloon catheter was used to complete the peripheral intervention procedure.No adverse effect has been reported as a result of this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction d10b: on the initial emdr this field was inadvertently left blank.The appropriate information has been provided.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufactures instructions, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection and functional test of the returned device confirmed that the surface of the catheter was smooth, clean, and not damaged.The balloon was successfully inflated to nominal pressure without issue.The clear coat peeling was noted on the balloon.The measurements taken for length and diameter of the device were 203mm and 2.69mm respectfully, which are both within specification.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.However, the subassembly lot did contain two nonconformances.The first was for ¿failed test leakage¿ (3 devices) and the second was for ¿peeling coating¿ (4 devices).All 7 nonconforming devices were destroyed prior to proceeding with the manufacturing process.It should also be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause can be traced to manufacturing deficiency.We will continue to monitor for 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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