Catalog Number 1012270-15 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/30/2019 |
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 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 before use in the cardiac cath lab room, the chip board box of a 2.0 x 15 mm mini trek balloon catheter was noted to be crushed and unopened.Therefore, the device was not used in any procedure.The sterility of the device was unknown.There was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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Internal file number: (b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported complaint was confirmed; however, the sterility of the pouch was not.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 complaint.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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