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Model Number M001125630 |
Device Problems
Detachment Of Device Component (1104); Torn Material (3024)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/11/2015 |
Event Type
Injury
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Event Description
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It was reported that balloon detachment and circumferential balloon tear occurred.The target lesion was located in the upper arm cephalic vein.A 9-8/5.8/40 blue max¿ balloon catheter was selected and advanced.The balloon was inflated at nominal pressure; however, circumferential balloon tear was noted.Upon removal of the device, it was noted that a portion of the balloon sheared off and was lodged within the treated vein.The procedure was completed with the implantation of a stent to jail the detached balloon and dilation was performed using a non-bsc balloon catheter.No further patient complications were reported and the patient's status was good and stable.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Device evaluated by mfr: a visual examination of the returned device identified that a complete balloon circumferential tear was present in the balloon.The tear was located at 4.7cm distal to the distal edge of the proximal markerband.The distal section of the balloon material tear was not received for analysis.No breaks were present in the shaft.A microscopic examination of the balloon material and proximal and distal markerbands identified no issues which could potentially have contributed to the tear.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 detachment and circumferential balloon tear occurred.The target lesion was located in the upper arm cephalic vein.A 9-8/5.8/40 blue max¿ balloon catheter was selected and advanced.The balloon was inflated at nominal pressure; however, circumferential balloon tear was noted.Upon removal of the device, it was noted that a portion of the balloon sheared off and was lodged within the treated vein.The procedure was completed with the implantation of a stent to jail the detached balloon and dilation was performed using a non-bsc balloon catheter.No further patient complications were reported and the patient's status was good and stable.
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Search Alerts/Recalls
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