Model Number 3851 |
Device Problems
Break (1069); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/23/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).
|
|
Event Description
|
It was reported that the device was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx3.50mm wolverine cutting balloon was selected for use.During the procedure, the delivery shaft of the balloon was fractured 120cm from the hub, and it could not cross.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
|
|
Manufacturer Narrative
|
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.Multiple kinks were noted along the hypotube shaft.No kinks or damages were noted along the polymer shaft.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.Multiple kinks were noted along the hypotube shaft.A microscopic examination of the proximal and distal markerbands identified no damage.
|
|
Event Description
|
It was reported that the device was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx3.50mm wolverine cutting balloon was selected for use.During the procedure, the delivery shaft of the balloon was fractured 120cm from the hub, and it could not cross.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
|
|
Search Alerts/Recalls
|