Model Number M001PCB7020900 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluated by manufacturer: the device was returned for analysis.
Visual and microscopic examination was performed on the returned device and the device was found to be consistent with the complaint event.
A pinhole leak was identified in the balloon material.
No other issues were noted with the returned device.
There were no issues with the blades of the device that could have potentially contributed to the complaint incident.
All blades were present and fully bonded to the balloon material.
The balloon was not folded which indicates that the balloon had been subjected to positive pressure.
The returned device was attached to an encore inflation unit and positive pressure was applied when liquid was observed escaping from a balloon pinhole leak approximately 7mm proximal to the proximal end of the distal markerband.
An examination of the balloon material identified no issues which could potentially have contributed to this complaint.
There were no issues with the tip or markerbands of the device that could have potentially contributed to the complaint incident.
No damage or any issues identified along the shaft of the device.
The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.
(b)(4).
|
|
Event Description
|
Same case as mdr id: 2134265-2017-12434.
It was reported that the balloon was broken and the blade got detached.
The target lesion was located in the pulmonary vein.
A 7mmx 2cmx 90cm 2cm peripheral cutting balloon® and a 6mx 2cmx 90cm 2cm peripheral cutting balloon® were selected for use.
During procedure, it was noted that the 7mm cutting balloon got broken upon deflation and was removed.
Then a 6mm cutting balloon was then used.
However, the blade of the balloon was noted to have fell off.
The procedure was completed with another device.
No patient complications were reported and patient's status was fine.
|
|
Manufacturer Narrative
|
Age at time of event: under 18 years.
(b)(4).
|
|
Event Description
|
Same case as mdr id: 2134265-2017-12434.
It was reported that the balloon was broken and the blade got detached.
The target lesion was located in the pulmonary vein.
A 7mmx 2cmx 90cm 2cm peripheral cutting balloon® and a 6mx 2cmx 90cm 2cm peripheral cutting balloon® were selected for use.
During procedure, it was noted that the 7mm cutting balloon got broken upon deflation and was removed.
Then a 6mm cutting balloon was then used.
However, the blade of the balloon was noted to have fell off.
The procedure was completed with another device.
No patient complications were reported and patient's status was fine.
|
|
Search Alerts/Recalls
|