Model Number H74939148308010 |
Device Problem
Torn Material (3024)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the 3.0 mm x 80 mm x 150 cm sterling¿ sl balloon was advanced to the superficial femoral artery and inflated twice.The distal portion of the balloon tore off while inside the patient.There was an attempt to remove the detached portion however it could not be recovered.The fragment was then pressed against the vessel wall with a stent where it remains inside the patient.The patient was reported to be doing fine.
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Manufacturer Narrative
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Device evaluated by mfr.The returned product consisted of a sterling sl balloon catheter, the distal portion of the balloon was not returned.Device analysis determined the condition of the returned device was consistent with the complaint incident.The balloon has a longitudinal tear starting 2mm from the proximal markerband sand continues to the distal end of the torn balloon.The balloon is completely circumferentially torn off 30mm from the proximal balloon weld and the distal portion of the balloon was not returned.There are numerous shaft kinks.The inner shaft is stretched.The tip is damaged.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that the 3.0mm x 80mm x 150cm sterling sl balloon was advanced to the superficial femoral artery and inflated twice.The distal portion of the balloon tore off while inside the patient.There was an attempt to remove the detached portion however it could not be recovered.The fragment was then pressed against the vessel wall with a stent where it remains inside the patient.The patient was reported to be doing fine.
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Search Alerts/Recalls
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