|
Model Number IPN917235 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/16/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
"it was reported that, during the initial injection of the contrast medium after insertion of the catheter, leak from the catheter occurred.Therefore, the user replaced the catheter with a new one, inserted at the same insertion site to complete the procedure.No patient injury was reported." the patient condition is reported as "fine".
|
|
Event Description
|
"it was reported that, during the initial injection of the contrast medium after insertion of the catheter, leak from the catheter occurred.Therefore, the user replaced the catheter with a new one, inserted at the same insertion site to complete the procedure.No patient injury was reported." the patient condition is reported as "fine".
|
|
Manufacturer Narrative
|
(b)(4).The reported lot number (16f22l0062) matches the lot number on the returned original packaging pouch/label.Returned for investigation was a 5fr.80cm berman catheter with the original packaging pouch.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.4cm to 88.7cm from the distal tip of the catheter; dried contrast media was noted within/around the ruptured catheter body.The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.Dried blood/contrast media was noted within the berman holes.No condensation was noted within the inflation lumen extension line.Spots of dried blood/contrast media was noted within the injection lumen extension line.Dried blood/contrast media was noted on the exterior surfaces of the returned sample.No other damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications of radius ratio less than or equal to 2.0.The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.The ruptured catheter body did not result in damage to the inflation lumen.The catheter's injection lumen was aspirated/flushed, and air was noted leaking from the ruptured catheter body.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that "during the initial injection of the contrast medium after insertion of the catheter, leak from the catheter occurred" is confirmed.The catheter body was found ruptured near the junction hub during visual inspection of the returned sample.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the ruptured catheter body.The probable root cause of the complaint is manufacturing related.Other remarks: n/a.Corrected data: n/a.
|
|
Search Alerts/Recalls
|
|
|