Catalog Number IAB-S840C |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that "used the straight sheath the sheath kinked upon placement and dr.Did not want to use the saf sheath.Removed sheath and placed a maquet/getinge iab successfully".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "critical" however the customer states that the device did not contribute to the patient's state of health.The patient was transferred to another facility.
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Manufacturer Narrative
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Qn#(b)(4) n/a other remarks: n/a corrected data: n/a.
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Event Description
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It was reported that "used the straight sheath the sheath kinked upon placement and dr.Did not want to use the saf sheath.Removed sheath and placed a maquet/getinge iab successfully".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "critical" however the customer states that the device did not contribute to the patient's state of health.The patient was transferred to another facility.
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Manufacturer Narrative
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Qn#(b)(4).The reported complaint of "sheath kinked" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.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.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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