On (b)(6) 2022, a nurse attempted to place a hydromid in an obese female patient and experienced difficulty getting the entire midline (pre-cut) to the measured tip location; it stopped after approximately 10cm*.The midline was removed, and a wire (not provided by avi) was inserted to confirm that the introducer was in the vein.The midline was then trimmed further and reinserted successfully.Brisk blood return and an easy flush was confirmed.On (b)(6) 2022, the nurse reported that the patient went to mri and power injection was to be used.Mri stated in their notes that they could not flush the hydromid, and a new line (not provided by avi) was placed in the patient's opposite hand for the mri.When eddie korycka (avi's clinical field director) arrived on site to discuss the reported complaint, the nurse stated that the line was flushing with difficulty.The lead clinician on the iv team, sean lau, attempted to flush and experienced a lot of resistance.The catheter was slowly pulled out while aspirating for blood return with no success.Upon removal, there was a burst noted in the distal third of the catheter.There was also a fatigued area at a section in the proximal half of the catheter.The iv team disposed of the catheter and the patient needed no other intervention.Due to the initial obstruction noted and the reported patient anatomy, the line may have been pinched off or occluded prior to power injection.If this did occur, an attempt at power injection may have contributed to the fatigue at the upper portion of the catheter and the burst at the lower third.This is unable to be confirmed, however, since the device was not returned to avi for investigation.The attending team should have acknowledged that the patient had the following contraindication, per the ifu (ls-015): anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures.
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