Catalog Number 1125400-12 |
Device Problems
Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that during device preparation and prior to use, the stent implant was noted to be dislodged from the balloon.The device was not used.There was no reported patient involved.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual and dimensional inspections were performed.The reported stent dislodgement was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.As there were crimp marks on balloon between the markers suggesting the stent was originally positioned correctly and securely at the time of manufacture, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual and dimensional inspections were performed.The reported stent dislodgement was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.As there were crimp marks on balloon between the markers suggesting the stent was originally positioned correctly and securely at the time of manufacture, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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