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Model Number 2213-01 |
Device Problems
Fracture (1260); Difficult to Remove (1528); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: the returned product consisted of a truselect 175cm microcatheter.The device shaft was microscopically analyzed for any damage.The device showed multiple bends and kinks along the entire shaft.The distal end of the shaft showed multiple fractures.The distal end looked to have a degrading issue.The distal shaft looked to be cracked and dried out.Fourier-transform infrared spectroscopy (ftir) was completed on this device, and it was noticed that an anti-bacterial wipe was used to wipe down the distal shaft.Anti-terra u is a wetting and dispersing additive that are in some over the counter bacterial wipes.The solution caused the outside shaft to deteriorate and degrade.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
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Event Description
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It was reported that fractures occurred.A 175cm truselect and a 014x200cm fathom guidewire were selected for use in a y90 procedure to treat hepatocellular carcinoma (hcc).The catheter was advanced with the guidewire through the tortuous anatomy.The guidewire was removed to take an angiogram.The guidewire was advanced again in attempt to advance the catheter a little further in the vessel where treatment was planned; however, advancement difficulty occurred due to the "curly q" in the vessel.After multiple unsuccessful attempts, the fathom and truselect were removed with resistance.Multiple fractures were noted on the truselect.A new truselect and fathom were used to complete the procedure.There were no patient complications.
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Search Alerts/Recalls
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