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Catalog Number LA6JR35 |
Device Problems
Component or Accessory Incompatibility (2897); Material Distortion (2977)
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Patient Problems
Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
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Event Date 01/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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The physician intended to use a 6f launcher guide catheter.There was no damage noted to the device packaging.The device was removed from the packaging per ifu.The device was inspected with no issues.The device was prepped per ifu with no issues.The device was not excessively torqued.The proximal right radial artery was the access site.The artery was non-tortuous and non-calcified.No resistance was noted when inserting the introducer.Resistance was experienced when inserting the catheter through the 6f non-mdt introducer, with another device inserted through the lumen of the guide catheter.The catheter was used on a teflon guidewire and a unidirectional valve.It is reported that at the moment of the transition from the introducer to the catheter the physician felt resistance of the proximal radial artery.Excessive force was not used during delivery.The physician tried once to rotate the launcher device to see if it would move better, but it did not work and dissection of the proximal third of the forearm occurred.The catheter was removed and it was noted that the tip was deformed- the tip was irregular.No portion of the catheter was detached.To treat the dissection, the introducer was removed and a local compression of the site was done.No additional intervention was required.The physician then changed the access point and the procedure was completed without complication.No further patient injury is reported.
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Manufacturer Narrative
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Product analysis summary; the catheter exhibited blood stains.As received the catheter was wavy.Closer visual inspection detected a crushed section on the shaft 25cm from the hub.During close inspection of the tip, white material damage was noted to the tip.The damage consisted of folding inward of the tip.During analysis the catheter was decontaminated, and visual inspection was conducted resulting in no noticeable damage.Actual physical measurements of the outer diameter and inner lumen met specification.The tip exposed length was also within specification.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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