Catalog Number 1012270-15 |
Device Problems
Detachment Of Device Component (1104); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is expected to be returned for evaluation.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 unpacking, when a 2.0 x 15 mm mini trek balloon catheter was removed from the pouch, the dispenser coil was severely kinked.An attempt was made to remove the catheter from the dispenser coil; however, the catheter shaft was separated.Another balloon catheter was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual inspection was performed on the returned device.The reported packaging damage/coil and the reported shaft separation were 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 from this lot.The investigation was unable to determine a conclusive cause for the reported packaging damage (kink); however, the reported shaft separation appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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