BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
|
Back to Search Results |
|
Model Number 3851 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.During the procedure, the device was advanced into the lesion; however, when it was inflated, it was noted that the balloon was already ruptured.The procedure was completed with another of the same device.No patient complications were reported.
|
|
Event Description
|
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.During the procedure, the device was advanced into the lesion; however, when it was inflated, it was noted that the balloon was already ruptured.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that during the procedure, at first inflation, it was noted that the balloon ruptured.The device was simply pulled out from the patient's body.There were no complications reported and the patient was good post procedure.
|
|
Manufacturer Narrative
|
Initial reporter city: (b)(6).
|
|
Manufacturer Narrative
|
E1 - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a pinhole at the proximal end of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine specification.The markerbands, blades and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple kinks on the hypotube of the device.No other issues were identified during the product analysis.
|
|
Event Description
|
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.During the procedure, the device was advanced into the lesion; however, when it was inflated, it was noted that the balloon was already ruptured.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that during the procedure, at first inflation, it was noted that the balloon ruptured.The device was simply pulled out from the patient's body.There were no complications reported and the patient was good post procedure.
|
|
Search Alerts/Recalls
|
|
|