BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24686 |
Device Problems
Break (1069); Material Rupture (1546)
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Patient Problem
No Code Available (3191)
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Event Date 12/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the radial vein.A 6f sheath was used for puncture and a guide wire crossed the lesion, a 6.0 x40, 75cm gladiator balloon catheter was advanced for dilation.However, when the balloon was inflated by degrees, but the balloon burst once nominal pressure was met.When the physician tried to remove the balloon, the catheter kinked.Then the physician adopted an open method and cut off the catheter and was able to retrieve the balloon successfully.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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(b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified a that the balloon material had torn circumferentially completely located approximately 5mm distal of the proximal markerband.Approximately 10mm of balloon material remained attached to the shaft of the device.A visual and tactile examination identified that the shaft was completely broken at approximately 34mm distal of the proximal markerband.The detached section of shaft has the distal markerband, tip and approximately 30mm of balloon material attached.The shaft was also noted to have kinks and stretching at more than one location.A visual microscopic examination identified no issues with the markerbands that could potentially have contributed to the complaint incident.A visual microscopic examination identified no issues with the tip that could potentially have contributed to the complaint incident.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 70% stenosed target lesion was located in the radial vein.A 6f sheath was used for puncture and a guide wire crossed the lesion, a 6.0 x40, 75cm gladiator balloon catheter was advanced for dilation.However, when the balloon was inflated by degrees, but the balloon burst once nominal pressure was met.When the physician tried to remove the balloon, the catheter kinked.Then the physician adopted an open method and cut off the catheter and was able to retrieve the balloon successfully.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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