Model Number 1012453-08 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.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 the procedure was to treat a lesion located in the proximal left anterior descending coronary artery that was mildly calcified and non-tortuous.A 3.0x33mm skypoint stent was successfully implanted and was post-dilated with two nc trek balloon dilatation catheters (bdc), a 3.5x15mm, and a 4.0x8mm.The 4.0x8mm was inflated once to 16 atmospheres (atm) for 20 seconds.During removal of the 4.0x8mm nc trek bdc, it could not be fully retracted into the guide catheter, so the devices were removed as a single unit.After the device was removed, it was noted that the balloon was still partially inflated.There was no reported 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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Visual, dimensional and functional inspections were performed on the returned device.The reported deflation was confirmed; however, the reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.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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