Catalog Number IAB-06830-U |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(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 "balloon catheter cannot detect arterial pressure.Doctor had to remove the alleged balloon and replaced with new one".Additional information states that the catheter was not replaced.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 that the "balloon catheter cannot detect arterial pressure" was not able to be confirmed as 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 was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "balloon catheter cannot detect arterial pressure.Doctor had to remove the alleged balloon and replaced with new one".Additional information states that the catheter was not replaced.No patient harm or injury.The patient status is reported as "fine".
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Search Alerts/Recalls
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