BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
|
Back to Search Results |
|
Model Number 24628 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified brachial vein.A 6.00 mm/2.0cm/50cm otw peripheral cutting balloon catheter was selected for use.During the procedure, the balloon was inflated twice at 10atm within 15 seconds accordingly.However, at second inflation, it was noted that the balloon ruptured.The physician's comment was "the pressure was applied with an appropriate method, but a balloon rupture did not occur for the first time.However, a balloon rupture has occurred when the pressure was applied for the second time." the device was removed without any problem using the normal method.The procedure was completed with another of the same device.No patient complications reported and the patient status was good.
|
|
Event Description
|
It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified brachial vein.A 6.00 mm/2.0cm/50cm otw peripheral cutting balloon catheter was selected for use.During the procedure, the balloon was inflated twice at 10atm within 15 seconds accordingly.However, at second inflation, it was noted that the balloon ruptured.The physician's comment was "the pressure was applied with an appropriate method, but a balloon rupture did not occur for the first time.However, a balloon rupture has occurred when the pressure was applied for the second time." the device was removed without any problem using the normal method.The procedure was completed with another of the same device.No patient complications reported and the patient status was good.
|
|
Manufacturer Narrative
|
E1 - initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 10mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.
|
|
Search Alerts/Recalls
|
|
|