Catalog Number 532642 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, there were blue flakes found within the packaging of a 6f multi-purpose (mp) a2 100cm 2 side-hole (sh) super torque angiographic catheter.The user put it to the side to give to supply and proceeded to get another catheter of the same size and curve.He inspected the packaging and noticed no defects.He handled off the catheter to a sterile technician.During the cardiac catheterization procedure under x-ray, the provider felt something on his hands.He looked down at his hands and noticed blue plastic flakes on his sterile gloves.When the lights came on (as they turn off when using x-rays) there was blue plastic flakes on the sterile field.There were no reports of patient injury.The provider changed out his sterile gloves and proceeded to remove the catheter that was in the right heart atrium.He did this as precaution since the blue flakes were the same color of the catheter that was removed.The sterile team inspected the field and removed any particles from the field.The entire item lot was removed from inventory.The devices will not be returned for evaluation.
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Manufacturer Narrative
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Section g3 was corrected to reflect the aware date of 22-mar-2024.
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Manufacturer Narrative
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Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, there were blue flakes found within the packaging of a 6f multi-purpose (mp) a2 100cm 2 side-hole (sh) super torque angiographic catheter.The user put it to the side to give to supply and proceeded to get another catheter of the same size and curve.He inspected the packaging and noticed no defects.He handled off the catheter to a sterile technician.During the cardiac catheterization procedure under x-ray, the provider felt something on his hands.He looked down at his hands and noticed blue plastic flakes on his sterile gloves.When the lights came on (as they turn off when using x-rays) there was blue plastic flakes on the sterile field.There were no reports of patient injury.The provider changed out his sterile gloves and proceeded to remove the catheter that was in the right heart atrium.He did this as precaution since the blue flakes were the same color of the catheter that was removed.The sterile team inspected the field and removed any particles from the field.The entire item lot was removed from inventory.At the two weeks post-op appointment, the patient complained of a brief 1-hour blurriness since the procedure.She did not seek out any medical care at that time and it has not happened since.The provider recommended patient to follow-up with her neurologist and inform them of the blurriness.No other issues were noted.The patient is pending another follow-up visit.The procedure was completed by removing the defective catheter and inserting another catheter (different company) in its place.Residue of catheter was removed from sterile field.The sheath was also changed out in case any residue was in the sheath.The provider stated there was no interaction was any equipment or products.The device was stored and prepped as per the instructions for use (ifu) states.The first catheter was inspected by the technician prior to opening.It contained plastic pieces in the package, so the technician did not give to the sterile team.The 2nd catheter the technician grabbed was inspected by him and contained no pieces.He opened the package and allowed the sterile technician to grab the catheter.The devices will be returned for evaluation.
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Search Alerts/Recalls
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