Model Number H7493918755200 |
Device Problems
Detachment Of Device Component (1104); Material Rupture (1546)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the severely calcified cephalic vein.A 5.5-2/4t/40 symmetry¿ 40 balloon catheter was advanced for dilation.However, when the balloon was inflated at 15 atmospheres, the balloon ruptured.There was a probability that a segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another 5.5-2/4t/40 symmetry¿ 40 balloon catheter.There were no patient complications nor injury reported.
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Manufacturer Narrative
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Device evaluated by mfr: a visual examination of the returned device identified a large circumferential tear 3mm distal of the proximal markerband with the tear extending longitudinally 10mm distally in the balloon material.The balloon was fully attached to the device and upon a visual examination of the balloon, there was no evidence that suggests balloon material detached from the device.An examination of the distal markerband identified no issues.A visual examination of the shaft identified no issues.Blood was identified in the lumen of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the severely calcified cephalic vein.A 5.5-2/4t/40 symmetry¿ 40 balloon catheter was advanced for dilation.However, when the balloon was inflated at 15 atmospheres, the balloon ruptured.There was a probability that a segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another 5.5-2/4t/40 symmetry¿ 40 balloon catheter.There were no patient complications nor injury reported.
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Search Alerts/Recalls
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