Catalog Number CS-25802-E |
Device Problems
Kinked (1339); Difficult To Position (1467)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 09/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information: it is unknown if the device sample is available for evaluation.
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Event Description
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The customer reports the doctor found it difficult to pass through the swg (spring wire guide), the insertion failed.The swg was checked and was found kinked.The device was replaced.
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Manufacturer Narrative
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(b)(4).The customer returned a guide wire assembly for evaluation.The guide wire was returned within the advancer tube.The advancer assembly was returned with the advancer tube partially disassembled.The guide wire was observed to have several kinks towards the distal end of the body and at the center of the body.The distal j-bend was kinked and slightly deformed but intact.Microscopic examination confirmed the kinks in the guide wire body.The straightener tube of the advancer assembly was observed to be cracked.Both welds were present and were observed to be full and spherical.The guide wire was kinked 30, 41 and 69mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed thro ugh both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and the catheter and no relevant manufacturing issues were identified.(con't) other remarks: 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.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked in several locations towards the distal tip.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.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 the doctor found it difficult to pass through the swg (spring wire guide), the insertion failed.The swg was checked and was found kinked.The device was replaced.
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Search Alerts/Recalls
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