It was reported that during insertion in icu, resistance was met resulting in the guide wire kinking.As a result, a new kit was opened and used without issue.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
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(b)(4).Device evaluation: the report that the guide wire kinked during insertion was confirmed.Returned was a guide wire.No other components were returned.The customer also provided a photo of the sample.The guide wire exhibited signs of use.It was kinked approximately 1 cm from the bottom of the j-bend.It was also kinked at 12.5 and 14 cm from the proximal end.A manual tug test confirmed that both welds were intact.The guide wire measured 60.2 cm in length, which was consistent with the guide wire graphic.The od of the guide wire measured 0.799mm.This met specification of 0.788 - 0.826mm per guide wire graphic.The guide wire is used with other components during insertion; however, the customer did not provide any details about the procedure and only returned the guide wire.The instruction booklet describes suggested techniques to minimize the likelihood of guide wire damage during use.A review of the device history records did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component during the procedure and no other components were returned, the probable cause of this issue could not be determined.No further action will be taken.
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