Model Number 1012274-30 |
Device Problem
Deflation Problem (1149)
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Patient Problem
Angina (1710)
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Event Date 02/17/2020 |
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.
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Event Description
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It was reported that the procedure was performed to treat a mildly calcified lesion in the proximal left anterior descending artery.A 3.0x30mm trek balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was inflated to 12-14 atmospheres; however, the balloon failed to fully deflate.After about 45 seconds, the balloon partially deflated and was removed.The patient had angina and it was managed subsequently.The procedure was successfully completed with a new unspecified trek bdc.There were no adverse patient sequela 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 deflation problem was able to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other incidents from this lot.The reported patient effect of angina is listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.The investigation determined the reported deflation problem appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.
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Event Description
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Additional information: the contrast mix was 50/50.The angina was treated with nitroglycerin.No additional information was provided.
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Search Alerts/Recalls
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