BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
|
Back to Search Results |
|
Model Number 7133 |
Device Problems
Break (1069); Material Deformation (2976)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/17/2018 |
Event Type
malfunction
|
Event Description
|
It was reported that shaft break occurred.A 2.50mm x 15mm fg emerge balloon catheter was advanced for treatment.However, when the device was inserted, the shaft bent and came apart from the balloon when it was removed.The procedure was completed with another of the same device.No patient complications were reported.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube, inflation lumen, and guidewire lumen.The hypotube is separated 80.9cm from the hub.Microscopic examination revealed no additional damages.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
|
|
Event Description
|
It was reported that shaft break occurred.A 2.50mm x 15mm fg emerge balloon catheter was advanced for treatment.However, when the device was inserted, the shaft bent and came apart from the balloon when it was removed.The procedure was completed with another of the same device.No patient complications were reported.
|
|
Search Alerts/Recalls
|
|
|