Catalog Number 1013151-15 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.The additional nc traveler devices referenced are being filed under separate medwatch report numbers.The nc traveler balloon dilatation catheter is currently not commercially available in the us; however, it is similar to a device sold in the us.
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Event Description
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It was reported that during inventory management, the dealer found that the chinese label was inconsistent with the english label.After verification, 15 nc traveler balloon dilatation catheters (bdc) were found in the distributor's inventory with english labeling: part #: 1013151-15, lot #: 20131g1 which is for a 2.5x15mm nc traveler and with chinese labeling: part #: 1013153-15, lot #:20203g1 which is for a 3.0x15mm nc traveler.There was no device use or patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual inspection was performed on the returned device.The reported device markings / labelling problem was confirmed.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed similar complaints from this lot which are associated with the exception issue.The investigation determined a potential product quality issue based on the reported and confirmed mismatching information between the addendum label and the product label.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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Search Alerts/Recalls
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