BOSTON SCIENTIFIC CORPORATION JETSTREAM SC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
|
Back to Search Results |
|
Model Number 45006 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/14/2021 |
Event Type
malfunction
|
Event Description
|
It was reported there was a catheter perforation.A 1.6mm jetstream sc catheter was selected for use in a right anterior tibial atherectomy procedure.During the procedure, it was noted a catheter perforation close to the control pod occurred.The device was exchanged, and the procedure was completed.The patient was reported in stable condition.
|
|
Manufacturer Narrative
|
Updated/additional information: b5: describe event or problem d4: lot number, expiration date, unique identifier (udi) # h4: device manufacture date device evaluated by manufacturer: a visual and microscopic examination revealed catheter shaft damage in the form of a severe kink located 142cm from the tip and two smaller damaged areas located 17.5cm from the tip.Functional testing revealed that during the priming sequence a leak was coming from the severe kink on the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of the device leaking fluid was confirmed.
|
|
Event Description
|
It was reported there was a catheter perforation.A 1.6mm jetstream sc catheter was selected for use in a right anterior tibial atherectomy procedure.During the procedure, it was noted a catheter perforation close to the control pod occurred.The device was exchanged, and the procedure was completed.The patient was reported in stable condition.It was further reported the perforation was on the catheter side, proximal to the pod.Saline solution was noticed dripping while retrieving the catheter after it had been advanced one time, from the femoral artery to the tibial arteries.
|
|
Search Alerts/Recalls
|
|
|