Catalog Number SI-11142 |
Device Problems
Kinked (1339); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The event was initially evaluated and determined to be non-reportable.The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore it is reportable.
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Event Description
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It was reported that during insertion in ane, the md was unable to advance the guide wire through the ars.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.
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Manufacturer Narrative
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(b)(4).Device evaluation: it was reported that the md was unable to advance the guide wire through the ars was confirmed.One opened si-11142 kit, containing a guide wire and numerous other components, was returned.The arrow raulerson syringe (ars) was not returned.The returned guide wire was observed to be kinked 2 cm from the j-tip.Microscopic evaluation also found an offset coil located 1 cm from the j-tip weld.Both welds were observed to be full and spherical.A manual tug test confirmed that both welds remain intact and the wire feels typical.The guide wire graphic specifies an outside diameter of.838/.877 mm and a length of 454 +/- 4 mm.The guide wire length was measured at 456 mm.The outside diameter measured.854 mm.Both measurements met specifications.The instructions booklet provided with the kit, describes suggested techniques to minimize the likelihood of guide wire damage during use.A device history record review was performed and did not reveal any manufacturing related issues.The probable cause of this issue could not be determined without a complete sample.No further action will be taken.
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Search Alerts/Recalls
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