ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
|
Back to Search Results |
|
Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Qn# (b)(4).
|
|
Event Description
|
It was reported that both sheaths in the kit had "profuse" bleeding back through the hemostasis valves.One sheath was bleeding back, and the user exchanged for the second sheath, which had the same issue.The user stated it stopped when the catheter was placed through the sheath, and he was able to use the catheter.There was no report of patient complications, serious injury or death.
|
|
Event Description
|
It was reported that both sheaths in the kit had "profuse" bleeding back through the hemostasis valves.One sheath was bleeding back, and the user exchanged for the second sheath, which had the same issue.The user stated it stopped when the catheter was placed through the sheath, and he was able to use the catheter.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).The product was not returned for investigation.The reported complaint of sheath leaked is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
|
|
Search Alerts/Recalls
|
|
|