BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
|
Back to Search Results |
|
Model Number 7020 |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 01/16/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that shaft break occurred.A 3.5mm x 20mm quantum maverick balloon catheter was selected for use.However, after unpacking the device, it was noticed that the shaft was fractured.No patient complications were reported and the patient was stable.
|
|
Manufacturer Narrative
|
The returned device consisted of a quantum maverick balloon catheter.The device was missing the hub, and the balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube and that 106cm of the device returned.The proximal end (separated edge) of the damaged hypotube was ovalized, consistent with being kinked prior to separating.The reported fracture was confirmed.
|
|
Event Description
|
It was reported that shaft break occurred.A 3.5mm x 20mm quantum maverick balloon catheter was selected for use.However, after unpacking the device, it was noticed that the shaft was fractured.No patient complications were reported and the patient was stable.
|
|
Search Alerts/Recalls
|
|
|