Catalog Number ASK-07155-UPM |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "the diaphragm present at the proximal end of the cordis that prevents bleed back after tvp insertion was faulty resulting in significant constant bleeding.As there was no underlying rhythm decision was made to bandage the proximal end as removing the tvp and replacing the sheath would have been extremely risky as there was no underlying rhythm.The distal locking mechanism of the sheath to the tvp , the one near the cordis was faulty and not working and the tvp wasn't being locked".Additional information received stated that "there was bleeding into the cath guard".The bleeding totaled "80-100cc, no transfusion needed".The cath guard was in the patient for "around 24 hours", the issue was resolved by putting "tight tegaderms in to stop the bleeding inside and the wire was sutured to the patient to prevent it from moving".No patient harm or injury.The patient status is reported as "fine".
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Event Description
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It was reported that "the diaphragm present at the proximal end of the cordis that prevents bleed back after tvp insertion was faulty resulting in significant constant bleeding.As there was no underlying rhythm decision was made to bandage the proximal end as removing the tvp and replacing the sheath would have been extremely risky as there was no underlying rhythm.The distal locking mechanism of the sheath to the tvp , the one near the cordis was faulty and not working and the tvp wasn't being locked".Additional information received stated that "there was bleeding into the cath guard".The bleeding totaled "80-100cc, no transfusion needed".The cath guard was in the patient for "around 24 hours", the issue was resolved by putting "tight tegaderms in to stop the bleeding inside and the wire was sutured to the patient to prevent it from moving".No patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).The reported complaint for sheath leak is not able to be confirmed.The product was not returned for investigation.No lot number was reported; therefore, a device history record (dhr) review was unable to be completed.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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