Model Number 1012274-15 |
Device Problems
Material Separation (1562); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2020 |
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.Na.
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Event Description
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It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, moderately tortuous, 90% stenosed proximal right coronary artery.A 3x15mm trek balloon dilatation catheter (bdc) was advanced with slight resistance with the anatomy.After deflation, the shaft separated, so the bdc was removed together with the whole system to 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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Event Description
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It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, moderately tortuous, 90% stenosed proximal right coronary artery.A 3x15mm trek balloon dilatation catheter (bdc) was advanced with slight resistance with the anatomy.After deflation, the shaft separated, so the bdc was removed together with the whole system to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the balloon of the 3x15mm trek balloon dilatation catheter (bdc) was separated.No additional information was provided.
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Manufacturer Narrative
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The device was returned for analysis.The reported shaft material separation and the reported balloon material separation was able to be confirmed.The reported difficult to advance was unable to 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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, moderately tortuous and 90% stenosed anatomy resulting in the reported difficult to advance.During removal, interaction with the heavily calcified, moderately tortuous and 90% stenosed anatomy and/or manipulation of the device resulted in the noted device damages (stretched inner/outer member, stretched/torn guide wire exit notch, bunched balloon, torn inner member, torn balloon) and ultimately resulted in the reported shaft/noted inner member material separation and the reported/noted balloon material separation.The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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Search Alerts/Recalls
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