Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
As reported, during an ¿aortoiliac angio¿ procedure, a cxi support catheter separated at the hub upon insertion of the device into an unknown catheter.During the same procedure, another cxi support catheter also separated.That event will be reported under patient identifier (b)(6).At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information was requested.
|