BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24628 |
Device Problems
Material Rupture (1546); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: (b)(6).Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).
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Event Description
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It was reported that the balloon ruptured.The 75% stenosed target lesion was located in the moderately tortuous vessel in the left forearm.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was inflated for 30 seconds.However, the stenosis remained at 4atm, thus the pressure was increased up to 6atm but there was still some constriction.Subsequently, the pressure was increased as it was but could no longer be increased above 6atm.When the device was deflated, blood was drawn in the plunger and so it was determined to have ruptured.Also, a pinhole was noted on the device.As per physician's opinion, the blade did not hit the lesion vertically, and it seems that the balloon was damaged by the blade.The procedure was completed with a different device.There no complications reported and patient was in good condition post procedure.
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Manufacturer Narrative
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A2.Age at time of event: 18 years or older.E1.Initial reporter address 1: (b)(6).E1.Initial reporter city: (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 device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 10mm proximal 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 10 atmospheres as per pcb2cm specification.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that the balloon ruptured.The 75% stenosed target lesion was located in the moderately tortuous vessel in the left forearm.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was inflated for 30 seconds.However, the stenosis remained at 4atm, thus the pressure was increased up to 6atm but there was still some constriction.Subsequently, the pressure was increased as it was but could no longer be increased above 6atm.When the device was deflated, blood was drawn in the plunger and so it was determined to have ruptured.Also, a pinhole was noted on the device.As per physician's opinion, the blade did not hit the lesion vertically, and it seems that the balloon was damaged by the blade.The procedure was completed with a different device.There no complications reported and patient was in good condition post procedure.
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