Model Number 1012272-15 |
Device Problems
Leak/Splash (1354); Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/10/2019 |
Event Type
malfunction
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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 complaints since the device was not returned for analysis and limited information was provided.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Event Description
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It was reported that prior to use, the 2.50x15mm rx trek balloon dilatation catheter was pressurized outside of the patient and a puncture was noted.A leak was noted from the puncture.The location of the puncture was not specified.There was no patient involvement.A new unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device returned for analysis.The reported leak and the reported material split, cut or torn were able to be confirmed.As there was no report of a leak during preparation for use and there was noted blood inside the guide wire lumen and in the balloon folds consistent with advancement, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3 - it was initially reported that the device would not be returning for analysis.Subsequent information revealed that the device was returned for evaluation.Method code 4114 was removed.Conclusion code 67 was removed.
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Search Alerts/Recalls
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