Catalog Number 1234250-18 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/28/2016 |
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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that during unpackaging, the physician removed the protective sheath from a 2.5x18mm absorb gt1 scaffold in accordance to our recommendation.During removal of the protective sheath, the scaffold dislodged from the delivery system.No resistance was felt during removal of the protective sheath.The device was replaced with another absorb scaffold which was successfully implanted.The patient is doing well.There was no adverse patient effect or clinically significant delay in the procedure.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 on the returned device.The reported scaffold dislodgement was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
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Search Alerts/Recalls
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