Model Number 6532 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(6).
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Event Description
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It was reported that the balloon raptured.The 70% stenosed target lesion was located in the non-tortuous and non-calcified distal right coronary artery.A 15mm x 4.00mm nc quantum apex catheters was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
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Manufacturer Narrative
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Age at time of event: 18 years or older.Initial reporter address: (b)(6).Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed that the tip is damaged.There is a pinhole in the balloon 5mm from the tip.There are two scratch marks at the pinhole approximately 3mm and 8mm long.The balloon is loosely folded.There is no indication the device was inflated over rated burst pressure.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that the balloon ruptured.The 70% stenosed target lesion was located in the non-tortuous and non-calcified distal right coronary artery.A 15mm x 4.00mm nc quantum apex catheters was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
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Search Alerts/Recalls
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