Catalog Number 1012454-15 |
Device Problems
Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2016 |
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.(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 relevant information.
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Event Description
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It was reported the procedure was to treat a lesion with no tortuosity and mild calcification in the mid right coronary artery (rca).The 4.5 x 15 mm nc trek balloon catheter was advanced to the target lesion without resistance noted.The nc trek balloon was inflated to 20 atmospheres two times and there were no issues noted during deflation.However, when the nc trek was to be withdrawn, the balloon could not be retrieved back into the 6fr guiding catheter.The devices had to be withdrawn together as one unit.Outside the patient anatomy, it was noted that the balloon was still partially inflated causing the resistance with the guiding catheter.The patient outcome was good.There was no adverse patient effect and no 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, dimensional and functional inspections were performed on the returned device.The reported difficulty to remove was confirmed.The partially inflated balloon could not be replicated in a testing environment as it was based on operational circumstances.It should be noted the instruction for use, states: balloon pressure should not exceed the rated burst pressure (rbp).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 determined the reported difficulty removing the device from the guiding catheter appears to be related to circumstances of the procedure; however, a conclusive cause for the reported partially inflated balloon could not be determined.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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