ICU MEDICAL, INC. TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC
|
Back to Search Results |
|
Catalog Number 412390406 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/10/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was discarded.No further information was obtained by the manufacturer.
|
|
Event Description
|
The reporter stated, during a cardiac catheterization the balloon ruptured.It was also reported that the customer has not made any changes to their sheath supplier or type and they routinely perform a ¿balloon up¿ test shortly after it¿s taken out of the package.There was no serious injury/harm, no adverse event, no medical intervention required and no delay in critical therapy.
|
|
Manufacturer Narrative
|
H10 - medsun medwatch received.
|
|
Search Alerts/Recalls
|
|
|