BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
|
Back to Search Results |
|
Model Number 7015 |
Device Problem
Inflation Problem (1310)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 25.2cm from the tip.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
|
|
Event Description
|
Reportable based on device analysis completed on 23apr2021.It was reported that balloon inflation failure occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced but could not be dilated after retracting.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.However, returned device analysis revealed shaft separation.
|
|
Search Alerts/Recalls
|
|
|