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Model Number N/A |
Device Problems
Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)
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Patient Problems
Dyspnea (1816); Pneumonia (2011); Sepsis (2067)
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Event Date 06/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This event is currently under investigation.
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Event Description
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The patient had an interventional radiology procedure done on (b)(6) 2015 involving 2 beacon tip catheters and a hiwire hydrophilic wire guide.In 2016, the patient was at another facility for a chest x-ray when it was noted that two pieces of the wire guide had fractured and remained in the patient.On (b)(6) 2016, the fragmented pieces were removed with a snare percutaneously and did not require a cutdown incision.The patient is doing very well.Event as listed on medwatch: "(b)(6) year old male admitted to angio suite at @0900 with pre-op sx.Of critical stenosis.Under mac, patient underwent percutaneous procedures as follows: transferred to pacu in stable condition.Discharged home on (b)(6) 2015.On (b)(6) 2016: patient presents to area hospital with three day history of coughing, fever dyspnea, vomiting and malaise.Patient is "septic, appears to have pneumonia".Incidental finding of retained foreign body (guidewire) noted in thoracic aorta extending up from the left groin and terminating in the aortic arch.Impression: retained foreign body ".The fragmented pieces were removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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(b)(4).During the course of the investigation, a review of the complaint history, instructions for use (ifu), and trends of the product was conducted.No product was returned to assist in this investigation.The provided ifu provides directions for use, warnings, and cautions regarding proper use of this device.Specifically, it states "use of alcohol, antiseptic solutions or other solvents must be avoided, because they may adversely affect the surface of the hydrophilic wire guide." "avoid manipulating or withdrawing the hydrophilic wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel." based on the information provided and as the actual complaint product was not returned to assist in the investigation, a root cause cannot be determined with certainty.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
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Event Description
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The patient had an interventional radiology procedure done on (b)(6) 2015 involving 2 beacon tip catheters and a hiwire hydrophilic wire guide.In 2016, the patient was at another facility for a chest x-ray when it was noted that two pieces of the wire guide had fractured and remained in the patient.On (b)(6) 2016, the fragmented pieces were removed with a snare percutaneously and did not require a cutdown incision.The patient is doing very well.Event as listed on medwatch." (b)(6) admitted to angio suite at @0900 with pre-op sx.Of critical stenosis.Under mac, patient underwent percutaneous procedures as follows: transferred to pacu in stable condition.Discharged home on (b)(6) 2015.On (b)(6) 2016: patient presents to area hospital with three day history of coughing, fever dyspnea, vomiting and malaise.Patient is "septic, appears to have pneumonia".Incidental finding of retained foreign body (guidewire) noted in thoracic aorta extending up from the left groin and terminating in the aortic arch.Impression: retained foreign body ".The fragmented pieces were removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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