Catalog Number 1012449-20 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.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 to treat a lesion in the right coronary artery.A 3.00 x 20 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure.There were no issues or leaks noted during prep (air aspiration) prior to use.During advancement of the bdc through the guide catheter, the physician attempted to put negative pressure on the balloon with the unspecified inflation device when he noticed that the plunger of the inflation device came back freely (no suction).The physician then noticed that the hub of the bdc had separated from the proximal shaft of the bdc.The bdc was removed from the anatomy and a new unspecified bdc was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.
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Manufacturer Narrative
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Internal file number -(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) confirmed the reported separation at the hub.Av reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other similar incidents reported from this lot.Av conducted root cause analysis and determined the issue may be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Av will continue to trend the performance of these devices.
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Search Alerts/Recalls
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