BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
|
Back to Search Results |
|
Model Number 24630 |
Device Problems
Failure to Advance (2524); Device Damaged by Another Device (2915)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 07/28/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
It was reported that there was bleeding and slit on sheath.Vascular access was obtained via ipsilateral approach.The 95% stenosed target lesion was located in the moderately calcified popliteal artery.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During procedure, the device was advanced after a guidewire passed through.However, the device had difficulty in crossing the lesion thus pre-dilation was performed with cob.The device was delivered again and dilatation was performed repeatedly for several times.Subsequently, bleeding was observed in the subcutaneous femoral when the sheath was removed.The blade of the balloon slit the sheath over its entire length in one direction causing the blood leaked.The bleeding was arrested by astriction.Per physician's opinion, the bleeding was caused by the balloon blade.The procedure was completed with this device.No further complications reported and patient was stable post procedure.
|
|
Manufacturer Narrative
|
E1-initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for analysis.The recommended sheath size as per ifu is a 6fr.The returned device was received together with customers 6fr introducer sheath.The customers sheath was torn along its entire length.As the customers sheath was torn the investigator selected a new 6fr introducer sheath for investigation purposes.On analysis, the investigator applied a vacuum and successfully advanced the device through a 6fr boston scientific introducer sheath and successfully withdrew the device without any resistance issues or damage to the sheath noted.No issues were noted that could have contributed to the complaint incident.All blades were present and fully bonded to the surface of the balloon.No issues were noted that may have potentially contributed to the complaint incident.The balloon was unfolded which indicates it had been subjected to positive pressure.No issues were identified with the balloon material that may have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found no damage or kinks on the shaft the device.No other issues were identified during the product analysis.
|
|
Event Description
|
It was reported that there was bleeding and slit on sheath.Vascular access was obtained via ipsilateral approach.The 95% stenosed target lesion was located in the moderately calcified popliteal artery.A 6.00mm/ 2.0cm/ 90cm peripheral cutting balloon was selected for use.During procedure, the device was advanced after a guidewire passed through.However, the device had difficulty in crossing the lesion thus pre-dilation was performed with cob.The device was delivered again and dilatation was performed repeatedly for several times.Subsequently, bleeding was observed in the subcutaneous femoral when the sheath was removed.The blade of the balloon slit the sheath over its entire length in one direction causing the blood leaked.The bleeding was arrested by astriction.Per physician's opinion, the bleeding was caused by the balloon blade.The procedure was completed with this device.No further complications reported and patient was stable post procedure.
|
|
Search Alerts/Recalls
|
|
|