ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; CATHETER, INTRAVASCULAR, THERAPEUTIC
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Catalog Number CDC-45703-P1A |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports that while the wire was being removed from the catheter, it would get stuck and could not be removed.One incident, the md pulled and the wire finally came out.The wire was extremely kinked.Another one had to remove the catheter because the wire was stuck".There was no injury or consequence to the patient reported.The patient's condition is reported as "fine".Therapy was reported to have been delayed/interrupted due to the alleged defect.
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Manufacturer Narrative
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(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing 2 kinks in the guide wire.The kinks are located along the body of the guide wire.The images show evidence of use on the guide wire.A device history record (dhr) review was performed on the guide wire and catheter and no relevant findings were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.Other remarks: the report that the guide wire kinked was confirmed through examination of the customer supplied photo.The image showed the guide wire kinked in several locations along the body; however, the actual complaint sample was not returned for evaluation.The dhr review for the guide wire and catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire kinking could not be determined based upon the information provided and without the actual complaint sample.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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The customer reports that while the wire was being removed from the catheter, it would get stuck and could not be removed.One incident, the md pulled and the wire finally came out.The wire was extremely kinked.Another one had to remove the catheter because the wire was stuck".There was no injury or consequence to the patient reported.The patient's condition is reported as "fine".Therapy was reported to have been delayed/interrupted due to the alleged defect.
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Search Alerts/Recalls
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