BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
|
Back to Search Results |
|
Model Number 3851 |
Device Problems
Break (1069); Entrapment of Device (1212)
|
Patient Problem
No Code Available (3191)
|
Event Date 07/22/2020 |
Event Type
Injury
|
Event Description
|
It was reported that the balloon was caught in the stent and became separated.The 2.5mm in diameter target lesion was located in the mildly calcified first diagonal (d1) artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was delivered and expanded in the target lesion passing through the stent strut that was previously placed in the left anterior descending artery (lad).The angle of lad and d1 was about 30 degrees on the angiography.However, when the device was removed, it was caught by the stent strut and could not be removed; so surgical treatment was performed.Furthermore, the device was separated when it was removed by surgery, but no fragments remained in the patient's body.The procedure could not be completed by percutaneous coronary intervention, but the intended treatment was completed.No further complications were reported and the patient was stable post procedure.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: the device was returned for analysis.The distal section of the device including the cutting balloon, markerbands and tip were not returned for analysis.A visual and tactile examination identified a break in the shaft polymer extrusion 210mm distal from guidewire exit port.It was a clean break and looks to have been cut by the surgeon during the attempt to remove the device.A visual and tactile examination identified multiple hypotube kinks.The manifold was also noted to be detached from the device.No other issues were identified during the product analysis.
|
|
Event Description
|
It was reported that the balloon was caught in the stent and became separated.The 2.5mm in diameter target lesion was located in the mildly calcified first diagonal (d1) artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was delivered and expanded in the target lesion passing through the stent strut that was previously placed in the left anterior descending artery (lad).The angle of lad and d1 was about 30 degrees on the angiography.However, when the device was removed, it was caught by the stent strut and could not be removed; so surgical treatment was performed.Furthermore, the device was separated when it was removed by surgery, but no fragments remained in the patient's body.The procedure could not be completed by percutaneous coronary intervention, but the intended treatment was completed.No further complications were reported and the patient was stable post procedure.
|
|
Search Alerts/Recalls
|
|
|