BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24630 |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/15/2022 |
Event Type
Injury
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Event Description
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It was reported that the device was difficult to remove.The target lesion was located in the superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, a resistance was felt upon insertion.Subsequently, the balloon was inflated twice at 6atm for 120 seconds.There was resistance upon removal and a tear was observed around 4-5 cm from the tip of the sheath which resulted in a subcutaneous bleeding.Hemostasis was performed as using a non-boston scientific seal device, and the procedure was completed successfully.No further patient complications were reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The device was returned with the customer's 6fr sheath, which was noted to be damaged.The recommended sheath size as per pcb2cm specification for this device is a minimum 6fr.On analysis, the investigator applied a vacuum using a 20ml syringe as per the instructions for use (ifu) pcb 2cm 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.No issues were noted that could have contributed to the complaint incident.A visual examination of the returned device confirmed that the balloon had been inflated.No issues or damage was noted with the balloon material, balloon profile or blades.All blades were present and fully bonded to the balloon material.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.
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Event Description
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It was reported that the device was difficult to remove.The target lesion was located in the superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, a resistance was felt upon insertion.Subsequently, the balloon was inflated twice at 6atm for 120 seconds.There was resistance upon removal and a tear was observed around 4-5 cm from the tip of the sheath which resulted in a subcutaneous bleeding.Hemostasis was performed as using a non-boston scientific seal device, and the procedure was completed successfully.No further patient complications were reported.
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