Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
|
Patient Problem
Injury (2348)
|
Event Date 10/28/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional information: the previously deployed stent was not dislodged or damaged.The physician attempted to use a snare to retrieve the balloon but was unsuccessful.The entire balloon was jailed in the distal sfa by deploying an everflex stent.No further treatment has been scheduled and the patient is doing fine.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Physician used a rapidcross balloon during treatment of a lesion in the patient¿s mid popliteal artery.Ifu was followed.No damage noted to packaging nor issues noted when removing the device from the hoop.Ifu was followed.The device was prepped without issue.An inflation device was used for balloon inflation.The rapidcross was passed through a previously deployed stent.Resistance was encountered when advancing the device.It is reported excessive force was used during withdrawal of the device as the balloon became caught on a previously deployed stent.This resulted in the balloon detaching from the catheter.The remnants of the balloon were then jailed by deploying a stent to cover.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|