Model Number 1012276-30 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2021 |
Event Type
malfunction
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Event Description
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It was reported the procedure was to treat a lesion in the mildly tortuous, mildly calcified distal right coronary artery.The 3.5 x 30 mm trek balloon dilatation catheter (bdc) was advanced to the target lesion for pre-dilatation without issue.It was inflated a couple of time between 12-14 atmospheres.During removal, the bdc got stuck in the guide catheter and the balloon detached inside the guide catheter.All the devices were removed together, including the detached balloon inside of the guide catheter.It was suspected the balloon did not fully deflate resulting in the difficult removal.An unspecified stent was implanted, completing the procedure.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for evaluation.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 and balloon separation appear 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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