Model Number 1012269-08 |
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 04/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
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Event Description
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It was reported that the procedure was performed to treat a heavily tortuous and moderately calcified chronic totally occluded lesion in the right coronary artery.A 1.5x8mm mini trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was advanced to the target lesion; however, resistance with the anatomy was felt.Additionally, the balloon ruptured.The procedure was successfully completed with an unspecified mini trek bdc.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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Visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.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 complaints appear to be related to operational context.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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