Catalog Number B2030-040 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/09/2014 |
Event Type
malfunction
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Event Description
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It was reported that during preparation of the 3.0mmx40mmx135cm armada 35 balloon dilatation catheter (bdc), air was continuously pulled, thus a leak was suspected.It was then noted that the bdc hub was cracked.The bdc was not used.Reportedly, there were no issues noted during unpackaging of the bdc prior to preparation.There was no reported patient involvement and no reported clinically significant delay in the procedure.Another 3.0mmx40mmx135cm armada 35 bdc was used to successfully complete the procedure.There was no additional information provided.
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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.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the returned device analysis was unable to confirm a crack but did identify a leak at the base of the hub, which was found when the balloon catheter was pressurized.A search of the complaint handling database was performed and found no other incidents identified from this lot for hub leaking issues.While a search of the lot history record for this specific lot indicated no related non-conformance records, based on an expanded investigation, a product issue related to leakage at the hub was identified.The event was possibly related to hub assembly during manufacturing.Corrective and preventative actions are in the process of being implemented.These devices will continue to be monitored.
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Search Alerts/Recalls
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