BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24686 |
Device Problems
Material Rupture (1546); Detachment of Device or Device Component (2907)
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Patient Problem
No Code Available (3191)
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Event Date 09/16/2019 |
Event Type
Injury
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in a left arteriovenous fistula.A 7.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 8.0 x 40, 75 cm gladiator elite balloon catheter; however, during inflation at 18 atmospheres, the balloon ruptured and the balloon parts came off.The broken fragments were completely removed from the patient's body with a snare.The procedure was completed with a non-bsc device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon material had a complete circumferential tear located approximately 20mm distal of the proximal markerband.Approximately 35mm of balloon material remained attached to the shaft of the device.The distal section of balloon material was not returned for analysis.A visual and tactile examination identified that the shaft was completely broken at approximately 72mm distal of the proximal markerband.The detached section of shaft, the distal markerband, the tip and distal section of balloon material were not returned for analysis.The shaft was also noted to be kinked and stretched distal of the balloon circumferential tear.This type of damage is consistent with excessive tensile force being applied to the device.A visual microscopic examination identified that only the proximal markerband remained intact on the device.The distal markerband was not returned for analysis.A visual microscopic examination identified that the tip was completely detached from the device.The tip was not returned for analysis.No other issues were identified during the product analysis.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in a left arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 8.0 x40, 75cm gladiator elite balloon catheter; however, during inflation at 18 atmospheres, the balloon ruptured and the balloon parts came off.The broken fragments were completely removed from the patient's body with a snare.The procedure was completed with a non-bsc device.No patient complications were reported and the patient's status was fine.It was further reported that there was a 90% stenosis, with non-calcified and non-tortuous target lesion.
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