Model Number 1012445-08 |
Device Problems
Material Rupture (1546); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2021 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was to treat a moderately calcified, moderately tortuous right coronary artery that is 90% stenosed.An unspecified guide wire crossed and a 3.5x10mm unspecified balloon failed to cross the lesion.The 2.0x8mm nc trek balloon dilatation catheter (bdc) was attempted to be used for pre-dilatation; however, the bdc ruptured at 12 atmospheres.It was noted during advancement resistance was felt with anatomy.Another 3.5x10 unspecified balloon was used along with a 4.0x15mm xience skypoint to complete the procedure successfully.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
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Manufacturer Narrative
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The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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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 determined the reported difficulties 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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