BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER
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Model Number N/A |
Device Problems
Device Dislodged or Dislocated (2923); Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rect1581 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that the catheterization operator felt resistance, after inserting the guide wire, when removing the guide wire.After the guide wire was removed, the outer layer of the guide wire was found dislocated.After careful observation, it was found that the guide wire was shorter than that normally used.It was stated that the facility was worried that the guide wire remained in the patient's body.No further information was provided.
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Event Description
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It was reported that the catheterization operator felt resistance, after inserting the guide wire, when removing the guide wire.After the guide wire was removed, the outer layer of the guide wire was found dislocated.After careful observation, it was found that the guide wire was shorter than that normally used.It was stated that the facility was worried that the guide wire remained in the patient's body.No further information was provided.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed and was determined to be use related.One 0.018 in.Guidewire was returned for evaluation.An initial visual observation showed use residue on the returned sample.One end of the guidewire was observed to be missing and the core wire was observed to be broken, which allowed the coiled wire to become unraveled.The core wire was measured from its broken end to the remaining weld tip and was found to be approximately 29 cm long.Microscopic observation revealed the break site of the core wire was angled with a mostly smooth surface.The fracture surface was observed to be lustrous with distinct striations.A slight ridge was also observed on the fracture surface.The angle, luster, and surface features of the break in the core wire suggest the guidewire was cut with a sharp instrument, most-likely scissors.A lot history review (lhr) of rect1581 showed no other similar product complaint(s) from this lot number.
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Search Alerts/Recalls
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