BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3851 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.The following attributes were examined.A visual examination of the balloon identified no damages.A hypotube break was identified, 19cm distal to the distal end of the strain relief and multiple hypotube kinks along the shaft of the device.No kinks or damages noted on the shaft polymer extrusion.For microscope analysis, 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.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal marker bands identified no damage.For device to device interaction test, the device could be loaded and tracked on a 0.014 inches test guidewire and 6fr guide catheter without issues.
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Event Description
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Reportable based on device investigation completed on (b)(6) 2023.It was reported that device kinked occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, significant resistance was encountered upon inserting this device into a boston scientific guide catheter and a device kinked was noted.The device was removed without any problem and the procedure was completed with another wolverine device.No complications reported.However, device analysis revealed that a hypotube break was identified, 19cm distal to the distal end of the strain relief.
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