Catalog Number 1012272-15 |
Device Problems
Difficult to Remove (1528); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number e2019001.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.Estimated date of occurrence.
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Event Description
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It was reported that the procedure was to treat a lesion.The trek balloon dilatation catheter (bdc), was successfully used to treat the lesion; however, during removal, the trek bdc, got caught and a portion of the balloon tore.Fortunately, the balloon remained attached to the catheter and the bdc was removed.No portion remains in the anatomy.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 was returned for analysis.The reported torn balloon could not be confirmed since the balloon portion was not returned; however, it is likely that the noted balloon and inner member separation is likely what the account perceived as the reported torn/separated balloon.The reported difficulty removing the device from the anatomy 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.B3: date of event.
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Event Description
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Subsequent to the initial 30-day medwatch report, the following information was received: the procedure was to treat a heavily calcified, 90% stenosed lesion in the left anterior descending coronary artery.During removal of the 2.5x15mm mini trek, the balloon dilatation catheter got caught on calcification.No additional information was provided.
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Search Alerts/Recalls
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