Catalog Number 1012454-15 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint handling database revealed no other incidents for slow deflation, difficult to remove from the guiding catheter or poor refold reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.
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Event Description
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It was reported that the procedure was to treat a left anterior descending artery.A 4.5 x 15 mm nc trek was deployed for post-dilatation; however, there was difficulty deflating the balloon.The balloon did finally deflate; however, it did not fold completely and it got stuck on the guiding catheter when removed from the patient.The procedure was completed at this time.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).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Search Alerts/Recalls
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