BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
|
Back to Search Results |
|
Model Number 7015 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/14/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient identifier: (b)(6).Device evaluated by mfr.: the returned product consisted of a quantum maverick catheter.The balloon was tightly folded.The tip, balloon, shaft and hypotube were microscopically and visually inspected.Inspection revealed a complete separation in the hypotube located 19.1 cm from the strain relief.The fracture faces were oval, as if kinked prior to separation.Inspection of the remainder of the device found no other damage or irregularities.
|
|
Event Description
|
Reportable based on device analysis completed on (b)(6) 2019.It was reported that shaft kink occurred.The 93% stenosed, 15mmx3.0mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced to dilate the lesion.However, it was observed that the delivery shaft was kinked and the kinked part was 20 cm away from the front hub.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent detached/separated.
|
|
Search Alerts/Recalls
|
|
|