Model Number 45007 |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/26/2018 |
Event Type
malfunction
|
Event Description
|
It was reported that the catheter stopped drilling.A 2.1mm jetstream catheter was selected for an athrectomy procedure in the superficial femoral artery (sfa).During the procedure, the catheter stopped drilling.The procedure was completed with another of the same device.There were no patient complications reported.
|
|
Manufacturer Narrative
|
Device analysis: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The shaft and the remainder of the device were inspected for damage.Visual examination showed that the baton was cut from the returned device.With the baton being cut and no infusion or aspiration lines the device cannot be functionally tested.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint for device rotational issues were not confirmed due to the incomplete device being returned for analysis.
|
|
Event Description
|
It was reported that the catheter stopped drilling.A 2.1mm jetstream catheter was selected for an athrectomy procedure in the superficial femoral artery (sfa).During the procedure, the catheter stopped drilling.The procedure was completed with another of the same device.There were no patient complications reported.
|
|
Search Alerts/Recalls
|